Page last updated: 2024-12-05

pseudoephedrine

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Description

Pseudoephedrine: A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

pseudoephedrine : A member of the class of the class of phenylethanolamines that is (1S)-2-(methylamino)-1-phenylethan-1-ol in which the pro-S hydrogen at position 2 is replaced by a methyl group. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID7028
CHEMBL ID1590
CHEBI ID51209
SCHEMBL ID4368
MeSH IDM0007541

Synonyms (115)

Synonym
BIDD:GT0817
pseudoefedrina
pseudoephedrinum
CHEBI:51209 ,
benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, (.alpha.s)-
BRD-K84175871-003-02-2
KBIO1_000451
DIVK1C_000451
NCI60_002955
besan
pseudoephedrine, l-(+)-
pseudoephedrine, (+)-
SPECTRUM_000878
PDSP1_001347
pseudoefedrina [inn-spanish]
pseudoephedrinum [inn-latin]
benzenemethanol, alpha-((1s)-1-(methylamino)ethyl)-, (alphas)-
einecs 202-018-6
pseudoephedrine [inn:ban]
pseudoephedrine (d)
alpha-(1-(methylamino)ethyl)benzyl alcohol
psi-ephedrine, (+)-
(1s,2s)-(+)-pseudoephedrine
hsdb 3177
benzenemethanol, alpha-(1-(methylamino)ethyl)-, (s-(r*,r*))-
NCGC00015408-01
lopac-e-3250
IDI1_000451
90-82-4
sudafed
trans-ephedrine
benzenemethanol, alpha-((1s)-1-(methylamino)ethyl)-, (alpha-s)-
l-(+)-pseudoephedrine
(+)-threo-ephedrine
isoephedrine
l(+)-psi-ephedrine
d-pseudoephedrine
(1s,2s)-2-(methylamino)-1-phenyl-propan-1-ol
SPECTRUM5_000650
BSPBIO_003261
(1s,2s)-2-(methylamino)-1-phenylpropan-1-ol
(+)-(1s,2s)-pseudoephedrine
C02765
pseudoephedrine
(+)-pseudoephedrine
d-psi-2-methylamino-1-phenyl-1-propanol
pseudoephedrine d-form
(+)-psi-ephedrine
psi-ephedrine
DB00852
d-isoephedrine
d-psi-ephedrine
(+) threo-2-(methylamino)-1-phenyl-1-propanol
psi-ephedrin
(1s,2s)-(+)-pseudoephedrine, 98%
KBIO3_002762
KBIO2_006494
KBIOGR_001763
KBIO2_001358
KBIOSS_001358
KBIO2_003926
SPECTRUM3_001771
SPECTRUM2_001303
SPBIO_001365
NINDS_000451
SPECTRUM4_001162
NCGC00178180-01
acunaso (tn)
pseudoephedrine (inn)
D08449
neodurasina (tn)
acunaso
pseudoephedrine polistirex
isoephedrine, d-
neodurasina
CHEMBL1590
(1s,2s)-2-methylamino-1-phenyl-propan-1-ol
pseudoephedrine ephedrine
unii-7cuc9ddi9f
7cuc9ddi9f ,
ec 202-018-6
pseudoephedrine [hsdb]
pseudoephedrine [inn]
1-(s),2-(r)-erythro-(+)-ephedrine
pseudoephedrine [mi]
pseudoephedrine [who-dd]
(.alpha.s)-.alpha.-((1r)-1-(methylamino)ethyl)benzenemethanol
benzenemethanol, .alpha.-(1-(methylamino)ethyl)-, (s-(r*,r*))-
benzenemethanol, .alpha.-((1s)-1-(methylamino)ethyl)-, (.alpha.s)-
pseudoephedrine [mart.]
pseudoephedrine [vandf]
ephedrine hydrochloride impurity b [ep impurity]
gtpl7286
pseudophedrine sulphate
(1s, 2s)-(+)-pseudoephedrine
(1s, 2s) pseudoephedrine
(1s,2s) pseudoephedrine
(+) pseudoephedrine
SCHEMBL4368
(1s,2s)-2-methylamino-1-phenylpropan-1-ol
DTXSID0023537 ,
AKOS025401512
d-pseudoephedrine base
SBI-0051498.P003
Q263958
ephedrine-(racemic)
(i)-ephedrin
dtxcid003537
pseudoephedrine (mart.)
(alphas)-alpha-((1r)-1-(methylamino)ethyl)benzenemethanol
pseudoefedrina (inn-spanish)
r01ba02
pseudoephedrine(d)
pseudoephedrinum (inn-latin)
(+)-pseudoephedrine, 1mg/ml in acetonitrile

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" 5 mg loratadine plus 120 mg pseudoephedrine was safe and effective in relieving the symptoms of allergic rhinitis."( [Evaluation of the efficiency and safety of the loratadine with pseudoephedrine combination drug in treatment of seasonal allergic rhinitis].
Lipiec, A; Rapiejko, P; Zawisza, E, 1998
)
0.3
"3%) were the most common treatment-related adverse effects."( A randomized, double-blind, parallel-group, multicenter, placebo-controlled study of the safety and efficacy of extended-release guaifenesin/pseudoephedrine hydrochloride for symptom relief as an adjunctive therapy to antibiotic treatment of acute respira
Gentile, DA; LaForce, C; Skoner, DP, 2008
)
0.35
" In the safety study, adverse events were reported for 18."( Multiple-dose pharmacokinetics and safety of an ibuprofen-pseudoephedrine cold suspension in children.
Gelotte, CK; Lavins, BJ; Pendley, C; Prior, MJ; Zimmerman, B, 2010
)
0.36
" Despite its high effectiveness, Ephedra Herb exert several adverse effects, including palpitation, excitation, insomnia, and dysuria."( [The Adverse Effects of Ephedra Herb and the Safety of Ephedrine Alkaloids-free Ephedra Herb Extract (EFE)].
Amakura, Y; Goda, Y; Hakamatsuka, T; Hanawa, T; Huang, X; Hyuga, M; Hyuga, S; Kobayashi, Y; Nakamori, S; Odaguchi, H; Oshima, N; Sekine, M; Shimada, N; Takemoto, H; Uchiyama, N; Yang, J, 2019
)
0.51
" However, its use is associated with adverse events that involve to a large extent the cardiovascular and the central nervous system."( In search of an ideal drug for safer treatment of obesity: The false promise of pseudoephedrine.
Bernardini, R; Burgaletto, C; Cantarella, G; Cortinovis, M; Di Mauro, R; Frara, S; Giustina, A; Munafò, A; Perico, N; Remuzzi, G, 2021
)
0.62

Pharmacokinetics

The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites. The method was successfully applied in a pharmacokinetic study of the acrivastine and pseudoephedrine hydrochloride compound capsule in humans.

ExcerptReferenceRelevance
" Results revealed that as the increase of urinary pH, the mean elimination half-life (t(1/2)), the mean residence time (MRT) and the area under the plasma concentration-time curve (AUC) of PPA, PSE, and FEN were greatly raised, while the total plasma clearance (CL/F) decreased considerably."( Influences of urinary pH on the pharmacokinetics of three amphetamine-type stimulants using a new high-performance liquid chromatographic method.
Feng, F; Wang, L; Wang, XQ; Zhu, L, 2009
)
0.35
" The method was successfully applied in a pharmacokinetic study of the acrivastine and pseudoephedrine hydrochloride compound capsule in humans."( Development and validation of a liquid chromatography-tandem mass spectrometry method for the simultaneous determination of acrivastine and pseudoephedrine in human plasma and its application in pharmacokinetics.
Dong, LC; Feng, EF; He, JC; Li, HL; Liu, M; Tian, M; Xu, GL; Zhang, Q, 2012
)
0.38
" Relevant pharmacokinetic parameters of rasagiline obtained after transdermal administration to minipigs were compared with those of rasagiline after oral administration."( Comparative single-dose pharmacokinetics of rasagiline in minipigs after oral dosing or transdermal administration via a newly developed patch.
Deng, J; Lin, J; Lin, Y; Zhang, T; Zou, Y, 2013
)
0.39
" Compared with single-herb extracts, alkaloids in plasma (except methylephedrine, benzoylmesaconine and benzoylhypaconine) showed slower elimination (the mean residence time or half-life was longer), although the maximum plasma concentration and area under the plasma concentration curve values decreased."( Simultaneous quantification and pharmacokinetics of alkaloids in Herba Ephedrae-Radix Aconiti Lateralis extracts.
Huo, H; Li, H; Luo, J; Song, S; Tang, Q; Xing, X,
)
0.13
" The pharmacokinetic properties of the individual components were evaluated in a randomized, open-label, four-period study in 12 healthy Chinese volunteers following single and multiple doses."( Pharmacokinetics of guaifenesin, pseudoephedrine and hydrocodone in a combination oral liquid formulation, administered as single and multiple doses in healthy Chinese volunteers, and comparison with data for individual compounds formulated as Antuss®.
Deng, S; Hu, J; Huang, W; Lu, H; Ni, X; Qiu, C; Shang, D; Wang, Z; Wen, Y; Xiong, L; Zhang, M; Zhang, Y; Zhu, X, 2017
)
0.46
"The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE)."( Multiple-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites and the Pharmacodynamic and Pharmacokinetic Interactions with Pseudoephedrine, a Sympathomimetic Agent, in Healthy Subjects.
Ghosh, A; Harris, S; Palmisano, M; Syto, M; Tran, JQ; Walker, S; Wang, X; Zhang, P, 2020
)
0.56

Bioavailability

Pseudoephedrine nanoparticles (PSE-NPs) with high bioavailability could overcome this limitation.

ExcerptReferenceRelevance
"The objectives of these studies were to characterize the pharmacokinetics (PK) of the nasal decongestant pseudoephedrine (PSE) in rats, dogs, and monkeys, and to evaluate its lower gastrointestinal tract regional bioavailability in rats."( Pharmacokinetics of pseudoephedrine in rats, dogs, monkeys and its pharmacokinetic-pharmacodynamic relationship in a feline model of nasal congestion.
Broske, L; Corboz, M; Korfmacher, W; McCormick, K; McLeod, RL; Mei, H; Morrison, R; Nomeir, AA; Palamanda, JR; Xu, X, 2010
)
0.36
" The dose-normalized relative bioavailability of rasagiline patch in minipig were 178."( Comparative single-dose pharmacokinetics of rasagiline in minipigs after oral dosing or transdermal administration via a newly developed patch.
Deng, J; Lin, J; Lin, Y; Zhang, T; Zou, Y, 2013
)
0.39
" On the other hand, following oral administration, pseudoephedrine fraction dose absorbed (F(abs)) and systemic bioavailability approaches 100%."( Regional-dependent intestinal permeability and BCS classification: elucidation of pH-related complexity in rats using pseudoephedrine.
Dahan, A; Fairstein, M; Swissa, R, 2013
)
0.39
" We postulated that pseudoephedrine nanoparticles (PSE-NPs) with high bioavailability could overcome this limitation."( Pseudoephedrine Nanoparticles Alleviate Adriamycin-Induced Reproductive Toxicity Through the GnRhR Signaling Pathway.
Chen, Y; Feng, W; Fu, Y; Gao, L; Li, P; Ruan, Y; Wei, Y; Yuan, P; Zheng, X; Zheng, Y, 2022
)
0.72

Dosage Studied

Pseudoephedrine (PSE) extracted from its dosage forms can be used as the starting material to prepare methamphetamine by drug abusers. The objective of the current study was to develop a simple, accurate and rapid reversed-phase HPLC method.

ExcerptRelevanceReference
" The method has been applied successfully to commercial tablet dosage form."( Kinetic spectrophotometric methods for the quantitation of triprolidine in bulk and in drug formulations.
Metwally, FH, 2001
)
0.31
" We explore the toxicities of OTC cough and cold medications, discuss mechanisms of dosing errors, and suggest why physicians should be more vigilant in specifically inquiring about OTCs when evaluating an ill child."( Toxicity of over-the-counter cough and cold medications.
Gunn, VL; Liebelt, EL; Serwint, JR; Taha, SH, 2001
)
0.31
"The objective of the current study was to develop a simple, accurate, precise and rapid reversed-phase HPLC method and subsequent validation using ICH suggested approach for the determination of antihistaminic-decongestant pharmaceutical dosage forms containing binary mixtures of pseudoephedrine hydrochloride (PSE) with fexofenadine hydrochloride (FEX) or cetirizine dihydrochloride (CET)."( Development and validation of a rapid RP-HPLC method for the determination of cetirizine or fexofenadine with pseudoephedrine in binary pharmaceutical dosage forms.
Karakuş, S; Küçükgüzel, I; Küçükgüzel, SG, 2008
)
0.35
"We developed and optimized a novel pseudoephedrine hydrochloride (PSE) sustained-release dosage form."( A novel approach to sustained pseudoephedrine release: differentially coated mini-tablets in HPMC capsules.
Abe, K; Hashizume, M; Ishida, M; Kawamura, M, 2008
)
0.35
"Pseudoephedrine exposure, mostly in the form of multiple-ingredient products, is common among US children, especially children who are younger than 2 years, who are at the highest risk for toxicity and for whom safe dosing recommendations are lacking."( Pseudoephedrine use among US children, 1999-2006: results from the Slone survey.
Kaufman, DW; Kelly, JP; Mitchell, AA; Vernacchio, L, 2008
)
0.35
" Patients were dosed with immediate-release formulations of phenylephrine, 12 mg, pseudoephedrine, 60 mg, as a control, or placebo."( A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber.
Danzig, M; Horak, F; Lemell, P; Staudinger, H; Yao, R; Zieglmayer, P; Zieglmayer, R, 2009
)
0.35
" Mean reductions in nasal congestion scores were comparable between the once- and twice-daily dosing regimens of the combination drug."( Desloratadine and pseudoephedrine combination therapy as a comprehensive treatment for allergic rhinitis and nasal congestion.
Anolik, R, 2009
)
0.35
" A standard-free electrospray ionization mass spectrometry method is used to directly determine the dosage in the prescription and over-the-counter drugs Tamiflu, Sudafed, and Dramamine."( Direct standard-free quantitation of Tamiflu and other pharmaceutical tablets using clustering agents with electrospray ionization mass spectrometry.
Flick, TG; Leib, RD; Williams, ER, 2010
)
0.36
" The bioavailability following intra-ileum or intra-colonic administration in rats was superior to that following oral dosing (66% and 78%, respectively) suggesting that colonic absorption may be compensating for the short half-life, thus enabling successful QD sustained release formulations of PSE."( Pharmacokinetics of pseudoephedrine in rats, dogs, monkeys and its pharmacokinetic-pharmacodynamic relationship in a feline model of nasal congestion.
Broske, L; Corboz, M; Korfmacher, W; McCormick, K; McLeod, RL; Mei, H; Morrison, R; Nomeir, AA; Palamanda, JR; Xu, X, 2010
)
0.36
"This study examined the effect of body-weight dosing of PSE on 800-m-run times of NCAA female runners."( Effect of pseudoephedrine on 800-m-run times of female collegiate track athletes.
Berry, C; Wagner, DR, 2012
)
0.38
" The prolonged t1/2 and increased bioavailability of rasagiline patch suggested a possible longer dosing interval compared with oral tablet."( Comparative single-dose pharmacokinetics of rasagiline in minipigs after oral dosing or transdermal administration via a newly developed patch.
Deng, J; Lin, J; Lin, Y; Zhang, T; Zou, Y, 2013
)
0.39
" This study is to obtain an effective extended release formulation using pseudoephedrine and KOB extracts to reduce side effects of drug due to repeated dosing and improve the compliance of patients for treatment of rhinitis and nasal decongestion."( A stable fixed-dose combination tablet of pseudoephedrine and KOB extracts for the extended release.
Cho, CW; Hwang, CJ; Jung, HW; Kang, JS; Kim, YH; Park, MH; Park, YK, 2013
)
0.39
"The purpose of the present study was to examine a possible dose-response between pre-exercise pseudoephedrine intake and cycling time trial performance."( The dose-response relationship between pseudoephedrine ingestion and exercise performance.
Jenkins, DG; Osborne, MA; Pritchard-Peschek, KR; Slater, GJ; Taaffe, DR, 2014
)
0.4
"Pseudoephedrine and cetirizine have been combined in dosage forms with more therapeutic benefits when compared with single-drug treatment."( Development of a CZE method for the quantification of pseudoephedrine and cetirizine.
Alnajjar, AO; Idris, AM, 2014
)
0.4
" A rapid, simple, selective and precise densitometric method was developed and validated for simultaneous estimation of six synthetic binary mixtures and their pharmaceutical dosage forms."( Thin layer chromatography-densitometric determination of some non-sedating antihistamines in combination with pseudoephedrine or acetaminophen in synthetic mixtures and in pharmaceutical formulations.
Atia, NN; El-Gizawy, SM; El-Kommos, ME; Hosny, NM, 2014
)
0.4
"Simple, accurate, and selective methods have been developed and validated for simultaneous determination of a ternary mixture of Chlorpheniramine maleate (CPM), Pseudoephedrine HCl (PSE) and Ibuprofen (IBF), in tablet dosage form."( Evaluating the efficiency of spectral resolution of univariate methods manipulating ratio spectra and comparing to multivariate methods: an application to ternary mixture in common cold preparation.
Ali, O; Hegazy, M; Moustafa, AA; Salem, H, 2015
)
0.42
" Across both multiple regression approaches, two tablets at first dosing were more effective than one and (except for ibuprofen-sensitive symptoms) starting treatment later than day 2 of the cold was generally less effective."( Factors associated with efficacy of an ibuprofen/pseudoephedrine combination drug in pharmacy customers with common cold symptoms.
Gräter, H; Klimek, L; Michel, MC; Mueck, T; Schumacher, H; Schütt, T, 2017
)
0.46
" It was pointed out that the proper evaluation of the efficiency of the release modification requires the examination of dosage forms as well as physical mixtures of API and excipient."( Dissolution studies of metamizole sodium and pseudoephedrine sulphate dosage forms - comparison and correlation of electronic tongue results with reference studies.
Cal, K; Ciosek-Skibińska, P; Wesoły, M; Wróblewski, W; Zabadaj, M, 2018
)
0.48
"Pseudoephedrine (PSE) extracted from its dosage forms can be used as the starting material to prepare methamphetamine by drug abusers."( Evaluation of commercially available meth-deterrent pseudoephedrine hydrochloride products.
Alayoubi, AY; Aqueel, MS; Ashraf, M; Chen, J; Cruz, CN; Korang-Yeboah, M; Rahman, Z; Zidan, AS, 2020
)
0.56
"A combination of paracetamol, pseudoephedrine, chlorpheniramine, and sodium benzoate in (Cold-Flu) 1,2,3 Syrup dosage form is specified for the treatment of common cold and flu symptoms."( Stability-Indicating New RP-UPLC Method for Simultaneous Determination of a Quaternary Mixture of Paracetamol, Pseudoephedrine, Chlorpheniramine, and Sodium Benzoate in (Cold-Flu) Syrup Dosage Form.
Mohamed, MA, 2022
)
0.72
"The functional role of this study is to develop a novel, reliable, and selective stability-indicating reversed-phase ultra-performance liquid chromatography (RP-UPLC) method for simultaneous identification of a quaternary mixture of paracetamol, pseudoephedrine, chlorpheniramine, and sodium benzoate in (Cold-Flu) 1,2,3 Syrup dosage form."( Stability-Indicating New RP-UPLC Method for Simultaneous Determination of a Quaternary Mixture of Paracetamol, Pseudoephedrine, Chlorpheniramine, and Sodium Benzoate in (Cold-Flu) Syrup Dosage Form.
Mohamed, MA, 2022
)
0.72
"The proposed stability-indicating UPLC method for simultaneous determination of the three drugs, paracetamol, pseudoephedrine, and chlorpheniramine, with a preservative sodium benzoate in (Cold-Flu) 1,2,3 Syrup dosage form is successfully accomplished, developed, and validated, and can be easily used in the analysis of drugs in pure or dosage form."( Stability-Indicating New RP-UPLC Method for Simultaneous Determination of a Quaternary Mixture of Paracetamol, Pseudoephedrine, Chlorpheniramine, and Sodium Benzoate in (Cold-Flu) Syrup Dosage Form.
Mohamed, MA, 2022
)
0.72
"The novelty of the current research work lies in the development of the UPLC method for simultaneous determination of a quaternary mixture of paracetamol, pseudoephedrine, chlorpheniramine, and sodium benzoate in (Cold-Flu) 1,2,3 Syrup dosage form."( Stability-Indicating New RP-UPLC Method for Simultaneous Determination of a Quaternary Mixture of Paracetamol, Pseudoephedrine, Chlorpheniramine, and Sodium Benzoate in (Cold-Flu) Syrup Dosage Form.
Mohamed, MA, 2022
)
0.72
"The developed methods are successfully applied for concurrent quantification of the studied components in the marketed dosage form without interference from matrix excipients."( Novel Spectrophotometric Approaches for the Simultaneous Quantification of Ternary Common Cold Mixture Containing Paracetamol with a Challenging Formulation Ratio: Greenness Profile Evaluation.
Fayez, YM; Monir, HH; Mostafa, NM; Rostom, Y; Soliman, RM, 2022
)
0.72
" The maximum dosage of Ephedrae herba should not exceed 10 g."( Ephedrae herba: A comprehensive review of its traditional uses, phytochemistry, pharmacology, and toxicology.
Luan, R; Mu, X; Pan, S; Zhao, P; Zheng, Q, 2023
)
0.91
" The E and PE contents per daily dosage in Kampo extracts were generally proportional to the compounding amount of Ephedrae Herba."( Comparison of ephedrine and pseudoephedrine contents in 34 Kampo extracts containing Ephedrae Herba used clinically in Japan.
Hakamatsuka, T; Hisaka, S; Homma, M; Kobayashi, R; Masada, S; Nose, M; Tada, M, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (8)

RoleDescription
sympathomimetic agentA drug that mimics the effects of stimulating postganglionic adrenergic sympathetic nerves. Included in this class are drugs that directly stimulate adrenergic receptors and drugs that act indirectly by provoking the release of adrenergic transmitters.
anti-asthmatic drugA drug used to treat asthma.
bronchodilator agentAn agent that causes an increase in the expansion of a bronchus or bronchial tubes.
vasoconstrictor agentDrug used to cause constriction of the blood vessels.
central nervous system drugA class of drugs producing both physiological and psychological effects through a variety of mechanisms involving the central nervous system.
nasal decongestantA drug used to relieve nasal congestion in the upper respiratory tract.
xenobioticA xenobiotic (Greek, xenos "foreign"; bios "life") is a compound that is foreign to a living organism. Principal xenobiotics include: drugs, carcinogens and various compounds that have been introduced into the environment by artificial means.
plant metaboliteAny eukaryotic metabolite produced during a metabolic reaction in plants, the kingdom that include flowering plants, conifers and other gymnosperms.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
secondary alcoholA secondary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has two other carbon atoms attached to it.
secondary amino compoundA compound formally derived from ammonia by replacing two hydrogen atoms by organyl groups.
phenylethanolaminesAn ethanolamine compound having a phenyl (substituted or unsubstituted) group on the carbon bearing the hydroxy substituent.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
ephedrine biosynthesis019

Protein Targets (37)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, HADH2 proteinHomo sapiens (human)Potency1.10800.025120.237639.8107AID886; AID893
Chain B, HADH2 proteinHomo sapiens (human)Potency1.10800.025120.237639.8107AID886; AID893
LuciferasePhotinus pyralis (common eastern firefly)Potency39.81070.007215.758889.3584AID411
RGS12Homo sapiens (human)Potency7.94330.794310.991425.1189AID879
15-lipoxygenase, partialHomo sapiens (human)Potency0.39810.012610.691788.5700AID887
NFKB1 protein, partialHomo sapiens (human)Potency28.18380.02827.055915.8489AID895; AID928
ThrombopoietinHomo sapiens (human)Potency3.16230.02517.304831.6228AID917; AID918
thyroid stimulating hormone receptorHomo sapiens (human)Potency0.12590.001318.074339.8107AID926
alpha-galactosidaseHomo sapiens (human)Potency32.46484.466818.391635.4813AID957; AID998
pyruvate kinaseLeishmania mexicana mexicanaPotency10.00000.398113.744731.6228AID945; AID959
cytochrome P450 2D6 isoform 1Homo sapiens (human)Potency12.58930.00207.533739.8107AID891
polyunsaturated fatty acid lipoxygenase ALOX12Homo sapiens (human)Potency3.16231.000012.232631.6228AID1452
cytochrome P450 2C19 precursorHomo sapiens (human)Potency1.58490.00255.840031.6228AID899
cytochrome P450 2C9 precursorHomo sapiens (human)Potency0.79430.00636.904339.8107AID883
guanine nucleotide-binding protein G(i) subunit alpha-1 isoform 1Homo sapiens (human)Potency7.94330.794312.126325.1189AID879
cytochrome P450 3A4 isoform 1Homo sapiens (human)Potency19.95260.031610.279239.8107AID884; AID885
lethal factor (plasmid)Bacillus anthracis str. A2012Potency0.01260.020010.786931.6228AID912
pyruvate kinase PKM isoform bHomo sapiens (human)Potency7.94332.511912.262825.1189AID954; AID958
Gamma-aminobutyric acid receptor subunit piRattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Polyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)Potency0.63100.316212.765731.6228AID881
Gamma-aminobutyric acid receptor subunit beta-1Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit deltaRattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-5Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-3Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-1Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-2Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-4Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-3Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-6Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Histamine H2 receptorCavia porcellus (domestic guinea pig)Potency0.72900.00638.235039.8107AID881; AID883
Gamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-3Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
GABA theta subunitRattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit epsilonRattus norvegicus (Norway rat)Potency19.95261.000012.224831.6228AID885
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (21)

Processvia Protein(s)Taxonomy
lipid metabolic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
phospholipid metabolic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
apoptotic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
negative regulation of cell population proliferationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
positive regulation of macrophage derived foam cell differentiationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
arachidonic acid metabolic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
negative regulation of cell migrationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
prostate gland developmentPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
regulation of epithelial cell differentiationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
positive regulation of chemokine productionPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
positive regulation of peroxisome proliferator activated receptor signaling pathwayPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
positive regulation of keratinocyte differentiationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
negative regulation of cell cyclePolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
negative regulation of growthPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
hepoxilin biosynthetic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
endocannabinoid signaling pathwayPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
cannabinoid biosynthetic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
lipoxin A4 biosynthetic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
linoleic acid metabolic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
lipid oxidationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
lipoxygenase pathwayPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (8)

Processvia Protein(s)Taxonomy
iron ion bindingPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
calcium ion bindingPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
protein bindingPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
lipid bindingPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
linoleate 13S-lipoxygenase activityPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
arachidonate 8(S)-lipoxygenase activityPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
arachidonate 15-lipoxygenase activityPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
linoleate 9S-lipoxygenase activityPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (8)

Processvia Protein(s)Taxonomy
nucleusPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
cytosolPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
cytoskeletonPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
plasma membranePolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
adherens junctionPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
focal adhesionPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
membranePolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
extracellular exosomePolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (31)

Assay IDTitleYearJournalArticle
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID350218Octanol-water partition coefficient, log PC of the compound2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Lipophilicity of basic drugs measured by hydrophilic interaction chromatography.
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID467613Volume of distribution at steady state in human2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID1253470Inhibition of recombinant human truncated SHIP2 using PI(3,4,5)P3diC8 at 1 mM after 30 mins by malachite green phosphatase release assay2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Synthesis and initial evaluation of quinoline-based inhibitors of the SH2-containing inositol 5'-phosphatase (SHIP).
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID467612Fraction unbound in human plasma2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID350220Lipophilicity, log K at pH 2 by by hydrophilic interaction chromatography using 100% water as mobile phase2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Lipophilicity of basic drugs measured by hydrophilic interaction chromatography.
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1253468Inhibition of recombinant human truncated SHIP1 using PI(3,4,5)P3diC8 at 1 mM after 30 mins by malachite green phosphatase release assay2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Synthesis and initial evaluation of quinoline-based inhibitors of the SH2-containing inositol 5'-phosphatase (SHIP).
AID350216Dissociation constant, pKa of the compound2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Lipophilicity of basic drugs measured by hydrophilic interaction chromatography.
AID350219Lipophilicity, log K at pH 2 by by hydrophilic interaction chromatography using 95% acetonitrile as mobile phase2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Lipophilicity of basic drugs measured by hydrophilic interaction chromatography.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID467611Dissociation constant, pKa of the compound2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID515780Intrinsic solubility of the compound in water2010Bioorganic & medicinal chemistry, Oct-01, Volume: 18, Issue:19
QSAR-based solubility model for drug-like compounds.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (397)

TimeframeStudies, This Drug (%)All Drugs %
pre-199048 (12.09)18.7374
1990's11 (2.77)18.2507
2000's80 (20.15)29.6817
2010's202 (50.88)24.3611
2020's56 (14.11)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials51 (11.94%)5.53%
Reviews24 (5.62%)6.00%
Case Studies54 (12.65%)4.05%
Observational1 (0.23%)0.25%
Other297 (69.56%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (82)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg of Dr. Reddy's Laboratories Ltd., India C [NCT03706300]Phase 180 participants (Actual)Interventional2014-12-31Completed
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Naproxen Sodium 220 mg + Pseudoephedrine HCL 120 mg ER Tablets and Aleve Cold and Sinus® Under Fasting Conditions. [NCT01131728]Phase 126 participants (Actual)Interventional2004-07-31Completed
A Randomized, Open Label, 2-treatment, Single Dose, Crossover, Bioequivalence Study of Ibuprofen 200 mg+Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare Under Fasting Conditions. [NCT01131780]Phase 132 participants (Actual)Interventional2004-10-31Completed
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy [NCT05697328]90 participants (Anticipated)Interventional2023-01-31Recruiting
A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Effect of Ozanimod on Blood Pressure and Heart Rate Response to Pseudoephedrine in Healthy Adult Subjects [NCT03644576]Phase 154 participants (Actual)Interventional2018-07-11Completed
Pretreatment With Topical Anesthesia or Decongestant for Reducing Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy: A Double Blind Randomized Study [NCT03620513]Phase 4160 participants (Actual)Interventional2018-09-01Completed
A Study to Investigate Continuous Blood Pressure Monitoring Using Traditional Device (ABPM) Versus Novel Devices (Biobeat and Aktiia) [NCT05692869]24 participants (Actual)Interventional2023-01-31Completed
Multicenter Clinical Trial, Phase III, Controlled, Open, Parallel Group, Randomized, Comparing the Fixed Dose Combination of Diphenhydramine + Dropropizine + Pseudoephedrine and the Combined Use of Dropropizine and Fixed Dose Combination of Pseudoephedrin [NCT01177852]Phase 30 participants (Actual)Interventional2011-10-31Withdrawn
Influence of a Bolus Administration of Ephedrine and Phenylephrine on the Spinal Oxygen Saturation, Measured With NIRS. [NCT03767296]Phase 433 participants (Actual)Interventional2017-02-06Completed
Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in the Relief of Allergic Symptoms in Rhinitic Patients With Viral Upper Respiratory Tract Infections and Productive Cough [NCT01085721]Phase 3170 participants (Anticipated)InterventionalNot yet recruiting
An Open-label, Randomised, Three-way Cross-over, Single Dose, Single Centre, Comparative Pharmacokinetic Study Between Ibuprofen and Pseudoephedrine Liquid Capsules (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Test), Ibuprofen and Pseudoephedrine Tablet [NCT03184766]Phase 155 participants (Actual)Interventional2016-08-10Completed
Effectivity of Combined Use of Ephedrine and Norepinephrine on Maternal Hemodynamics in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia [NCT03672071]90 participants (Anticipated)Interventional2018-09-30Recruiting
Determination of the Optimal Dose of Ephedrine in Intraoperative Arterial Hypotension of Newborns and Infants up to 6 Months of Age. A Randomized, Controlled, Open-label, Dose Escalation Study. [NCT02384876]Phase 2120 participants (Actual)Interventional2015-06-30Completed
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in at Least 48 [NCT02963701]Phase 156 participants (Actual)Interventional2016-12-20Completed
The Effects of Position and Predictive Factors on Hypotension in Patients Undergoing Prone Percutaneous Nephrolithotomy [NCT05827705]153 participants (Actual)Observational2021-03-01Completed
A Phase 2, Double-Blind, Parallel-Group, Dose-Ranging Study Evaluating Safety/ Efficacy Atropine Doses With Pseudoephedrine and Chlorpheniramine in SAR Patients 12 Years of Age and Older [NCT02082054]Phase 2125 participants (Anticipated)Interventional2014-03-31Active, not recruiting
Double-blind, Randomized, Parallel Trial to Evaluate the Clinical Efficacy and Safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, Twice a Day, Versus Epinastine 10 mg Alone, Twice a Day, in the Treatment of Outpatients With Perennial Allergic Rhiniti [NCT02182518]Phase 3101 participants (Actual)Interventional2000-05-31Completed
Study of the Decongestant Effect of SCH 900538 Compared With Placebo and Pseudoephedrine as Active Control in Subjects With Seasonal Allergic Rhinitis (SAR) Exposed to Pollen in an Environmental Exposure Unit [NCT00673062]Phase 2265 participants (Actual)Interventional2008-05-31Completed
Non-interventional Study on the Quality of Life Before and After Intake of Sinolpan® (Forte) in Inflammatory Diseases of the Respiratory Tract - an Anonymous Patient Survey [NCT04703673]350 participants (Actual)Observational2021-01-08Completed
A Randomized, Open Label, 2-treatment, Single Dose, Crossover, Bioequivalence Study of Ibuprofen 200 mg+Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare Under Fed Conditions. [NCT01132222]Phase 134 participants (Actual)Interventional2004-09-30Completed
Randomized Clinical Study for Efficacy Assessment Between Cloratadd-D, Loratadine + Pseudoephedrine (Coated Pill), Produced by EMS S/A Laboratories and Allegra-D , Produced by Sanofi-Aventis for Patients With Perennial Allergic Rhinitis. [NCT01228630]Phase 3156 participants (Actual)Interventional2011-08-31Completed
An Open Label, Balanced, Randomized, Two-way, Single Dose, Crossover Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tabs of Dr. Reddy's and Allegra-D 24 hr ER Tabs of Aventis, in Healthy Subjects Under Fasting Conditions [NCT01133470]Phase 154 participants (Actual)Interventional2007-02-28Completed
A Randomized, Crossover Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-SAG) to a Single Oral Dose of Claritin-D® 1 [NCT03517930]Phase 152 participants (Actual)Interventional2018-04-17Completed
Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fasting Conditions [NCT01373138]Phase 134 participants (Actual)Interventional2006-04-30Completed
Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Male and Female [NCT01170637]Phase 147 participants (Actual)Interventional2010-07-31Completed
Title: The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain Due to Propofol Injection in Patients Undergoing Elective Surgery Under General Anaesthesia [NCT01186549]Phase 1/Phase 2165 participants (Actual)Interventional2010-08-31Completed
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Naproxen Sodium 220 mg + Pseudoephedrine HCL 120 mg ER Tablets and Aleve Cold and Sinus® Under Fed Conditions. [NCT01131767]Phase 126 participants (Actual)Interventional2004-07-31Completed
An Open Label, Balanced, Randomized, Two-way, Single Dose, Crossover Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tabs of Dr. Reddy's and Allegra-D 24 hr ER Tabs of Aventis, in Healthy Subjects Under Fed Conditions [NCT01133483]Phase 138 participants (Actual)Interventional2007-04-30Completed
A Randomized, Double Blind, Parallel Group Study for Assessing the Efficacy and Safety of a Twice-daily Fexofenadine HCl 60 mg - Pseudoephedrine HCl 60 mg Combination or Fexofenadine HCl 60 mg - Pseudoephedrine HCl 120 mg Combination Versus Allegra® 60 mg [NCT01306721]Phase 3520 participants (Actual)Interventional2011-02-28Completed
Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters [NCT01028014]56 participants (Actual)Interventional2010-04-30Completed
Effect of Drinking Water on the Pressor Response to Pseudoephedrine in Patients With Autonomic Failure [NCT02149901]Early Phase 135 participants (Anticipated)Interventional2014-10-31Terminated(stopped due to funding terminated)
Biphasic Effects of Different Doses Ephedrine on Hemodynamics in Elderly Patients Under General Anesthesia [NCT04934852]70 participants (Anticipated)Interventional2021-07-01Recruiting
A Study to Assess the Speed of Relief From Nasal Congestion With a Hypertonic Saline Nasal Spray (Phytosun Decongestant) [NCT02100605]50 participants (Actual)Interventional2014-03-31Completed
Study of the Pharmacokinetic Interactions and Relative Bioavailability of Epinastine and Pseudoephedrine in Healthy Volunteers, Comparing Tablets Containing the Fixed Combination of the Two Substances With Tablets Containing Each of the Two Substances Sep [NCT02182531]Phase 125 participants (Actual)Interventional1999-08-31Completed
Cerebral Hemodynamic and Metabolic Responses to Anesthesia and Vasopressors in Adult Surgery: A 2x2 Factorial Design Randomized Controlled Trial With Light-based Neuromonitoring (CHEM-FACT Study) [NCT05941494]Phase 480 participants (Anticipated)Interventional2023-10-03Recruiting
Comparative, Randomized, Single Dose, 2 Way Crossover Bioavailability Study of Ranbaxy and Warner - Lambert (Sudafed ® 12 Hour) 120 mg Pseudoephedrine Hydrochloride Extended - Release Tablets in Healthy Adult Volunteers Under Fasting Conditions. [NCT00779831]36 participants (Actual)Interventional2004-06-30Completed
Pharmacological or Non-Pharmacological Management of Maternal Hypotension During Elective Cesarean Section Under Subarachnoid Anesthesia: a Randomized, Controlled Trial [NCT00991627]Phase 436 participants (Anticipated)Interventional2009-09-30Completed
Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation [NCT01015794]25 participants (Actual)Interventional2009-12-31Completed
A Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Acetylsalicylic Acid Combined With Pseudoephedrine, Compared With Acetylsalicylic Acid Alone, and Pseudoephedrine Alone, on Symptoms of Pain. [NCT00963443]Phase 3833 participants (Actual)Interventional2009-09-30Completed
Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study) [NCT00377403]Phase 4172 participants (Actual)Interventional2006-10-31Completed
A Randomized, Single-Dose, Single-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-Over Study to Compare the Relative Efficacy of JNJ-39220675, Pseudoephedrine and Placebo for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber [NCT00804687]Phase 253 participants (Actual)Interventional2008-11-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Safety and Efficacy of Mucinex D for Symptomatic Therapy in Patients With Acute Upper Respiratory Tract Who Seek Treatment [NCT01202279]Phase 41,179 participants (Actual)Interventional2009-10-31Completed
An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Pseudoephedrine Hydrochloride Formulations Comparing Pseudoephedrine Hydrochloride 120 mg ER Tablets of Ranbaxy Laboratories With [NCT00779805]40 participants (Actual)Interventional2004-06-30Completed
Evaluation of Nasal Congestion Clinical Efficacy for Diphenhydramine 25 mg and Diphenhydramine 50 mg in Seasonal Allergic Rhinitis: a Randomized, Double-blind, Placebo and Pseudoephedrine Controlled Study [NCT00648973]Phase 41,021 participants (Actual)Interventional2006-11-30Completed
Comparative, Randomized, Single-Dose, Fully Replicated, 4-Way Crossover Bioavailability Study of Ranbaxy and Schering (Claritin_D® 24 Hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in Healthy Adult Volunteers Under Fasting [NCT00837915]40 participants (Actual)Interventional2002-06-30Completed
Multicenter, Phase III, Randomized, Open, Parallel, Comparative to Evaluate the Efficacy and Safety of the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis and Allergic Reactions, in Pediatric Patients [NCT01393548]Phase 3879 participants (Actual)Interventional2014-08-31Completed
A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fasting Conditions [NCT00881127]Phase 140 participants (Actual)Interventional2005-07-31Completed
A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fed Conditions [NCT00881634]Phase 140 participants (Actual)Interventional2005-06-30Completed
Crossover Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber [NCT00276016]Phase 339 participants (Actual)Interventional2006-01-31Completed
A Pivotal, Placebo Controlled, Phase III Study to Compare Efficacy and Tolerability of a Fixed Combination, Containing 500 mg ASA and 30 mg Pseudoephedrine, in Comparison to Its Single Components in Patients With Sore Throat and Nasal Congestion [NCT01062360]Phase 31,016 participants (Actual)Interventional2005-12-23Completed
Evaluation and Treatment of Autonomic Failure. [NCT00223691]Phase 1389 participants (Actual)Interventional2002-03-31Completed
Comparative, Randomized, Single-Dose, Fully Replicated, 4-Way Crossover Bioavailability Study of Ranbaxy and Schering (Claritin_D® 24 Hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in Healthy Adult Volunteers Under Fed Con [NCT00845546]40 participants (Actual)Interventional2002-06-30Completed
Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block - Time to Event Analysis. [NCT05993182]Phase 4300 participants (Anticipated)Interventional2023-08-20Recruiting
The Effect of Pseudoephedrine on Rhinitis and Sleep [NCT00704496]Phase 334 participants (Actual)Interventional2007-06-30Completed
A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Mucinex D as Adjunct Therapy to Antibiotic Treatment of Acute Respiratory Infection [NCT00441246]Phase 4600 participants (Anticipated)Interventional2007-02-28Completed
A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy's Reproducibility of a Combination of Pseudoephedrine and Cetirizine on Symptom Scores and Rhinomanometry in Patients With Allergic Rhinitis Following Pollen Exposure in [NCT00474890]70 participants (Anticipated)Interventional2007-06-30Completed
An Investigation to Evaluate the Technique of MRI as an Assessment of the Effect of Anti-allergy Drug Treatment on Internal Nasal and Sinus Mucosal Anatomy Following Intranasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis. [NCT00517946]21 participants (Actual)Observational2007-03-31Completed
A Study to Investigate Continuous Heart Rate Monitoring Using a Chest-worn Biosensor on the Background of Drug-induced Positive and Negative Heart Rate Changes [NCT04682184]21 participants (Actual)Interventional2021-01-27Completed
A Community Pharmacy Based Investigation in the Self-Medication Area Efficacy and Safety of Sinutab and Pseudoephedrine on Subjects With Nasal Congestion Accompanied by Headache in the Setting of a Common Cold [NCT00378144]Phase 4469 participants (Actual)Interventional2007-01-31Completed
"Evaluation of Histamine, CGRP and VIP as Biological Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers in Response to Sinus Symptoms" [NCT00208065]Phase 450 participants Interventional2004-05-31Completed
[NCT01055756]Phase 30 participants (Actual)Interventional2010-01-31Withdrawn
Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis [NCT00000752]Phase 20 participants (Actual)InterventionalWithdrawn
The Autonomic Nervous System and Obesity [NCT00179023]Phase 1128 participants (Actual)Interventional2003-04-30Completed
A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial) [NCT05720455]Phase 4203 participants (Anticipated)Interventional2024-07-21Not yet recruiting
A Comparative Study of Coadministered Doses of Ibuprofen and Pseudoephedrine HCl and Each Drug Alone in the Treatment of Primary Nocturnal Enuresis in Children [NCT00240812]Phase 2318 participants (Actual)InterventionalCompleted
A Randomized, Double Blind, Placebo-controlled, Four Way Cross-over Study to Assess the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Cetirizine Alone on Symptoms Scores and Rhinomanometry in Patients With Allergic Rhinitis Following P [NCT00334698]51 participants (Anticipated)Interventional2006-07-31Completed
Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fed Conditions [NCT01506791]Phase 144 participants (Actual)Interventional2006-04-30Completed
Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial [NCT01509209]Phase 3137 participants (Actual)Interventional2011-05-31Completed
The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine [NCT01509521]Phase 424 participants (Anticipated)Interventional2012-02-29Completed
The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man [NCT01710722]45 participants (Actual)Interventional2001-02-28Completed
A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold [NCT01744106]Phase 3565 participants (Actual)Interventional2012-11-30Completed
Middle Ear Pressure Regulation in Health and Disease -- Gas Supply, Demand and Middle Ear Gas Balance -- Specific Aim 2 [NCT01925729]Phase 184 participants (Actual)Interventional2013-10-01Completed
Treatment of Low Metabolic Rate and Low Weight Loss Rate Following Bariatric Surgery [NCT01596907]218 participants (Actual)Interventional2012-05-31Completed
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/30 mg Tablets Under Fasting Conditions [NCT03429738]Phase 166 participants (Actual)Interventional2014-04-27Completed
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis [NCT00002149]40 participants InterventionalCompleted
HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients: The HISTAP Randomized Clinical Trial. [NCT05637606]636 participants (Anticipated)Interventional2023-03-06Recruiting
"Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Equipotent Prophylactic Doses of Ephedrine, Phenylephrine, Norepinephrine vs Placebo." [NCT03864094]Phase 499 participants (Anticipated)Interventional2022-03-15Recruiting
Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial [NCT05127876]Phase 4168 participants (Actual)Interventional2022-01-10Completed
An Open Label, In-use Study to Assess the Warming Sensation, Acceptability and Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup Given as a 30 ml Single Dose in Subjects Suffering From Symptoms of an Upper Respiratory Tract Infection [NCT01586962]Phase 356 participants (Actual)Interventional2012-05-31Completed
A Double-Blind Placebo-Controlled Crossover Study to Evaluate Objective Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure in an Environmental Exposure Unit [NCT03443843]Phase 482 participants (Actual)Interventional2018-02-21Completed
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy [NCT04332211]Phase 4105 participants (Actual)Interventional2021-05-01Active, not recruiting
A Randomized, Crossover Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-SAG) to a Single Oral Dose of Claritin-D® 1 [NCT03517943]Phase 129 participants (Actual)Interventional2018-04-24Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00276016 (2) [back to overview]The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo
NCT00276016 (2) [back to overview]The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.
NCT00377403 (1) [back to overview]SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3
NCT00804687 (4) [back to overview]Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry
NCT00804687 (4) [back to overview]Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)
NCT00804687 (4) [back to overview]Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1
NCT00804687 (4) [back to overview]Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.
NCT01202279 (2) [back to overview]Antibiotic Sparing
NCT01202279 (2) [back to overview]Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
NCT01586962 (3) [back to overview]Safety and Tolerability of the Syrup
NCT01586962 (3) [back to overview]Subject Acceptability of the Syrup
NCT01586962 (3) [back to overview]Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup
NCT02963701 (13) [back to overview]Area Under the Concentration-time Curve of Ibuprofen in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
NCT02963701 (13) [back to overview]Area Under the Concentration-time Curve of Pseudoephedrine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
NCT02963701 (13) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Ibuprofen. (AUC0-tz)
NCT02963701 (13) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Pseudoephedrine (AUC0-tz).
NCT02963701 (13) [back to overview]AUC0-∞ of R-Ibuprofen
NCT02963701 (13) [back to overview]AUC0-∞ of S-Ibuprofen
NCT02963701 (13) [back to overview]AUC0-tz of R-Ibuprofen
NCT02963701 (13) [back to overview]AUC0-tz of S-Ibuprofen
NCT02963701 (13) [back to overview]Cmax of R-Ibuprofen
NCT02963701 (13) [back to overview]Cmax of S-Ibuprofen
NCT02963701 (13) [back to overview]Maximum Concentration of Ibuprofen in Plasma (Cmax).
NCT02963701 (13) [back to overview]Maximum Concentration of Pseudoephedrine in Plasma (Cmax).
NCT02963701 (13) [back to overview]S/R-ibuprofen Ratio for AUC0-tz

The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo

"To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing.~The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results." (NCT00276016)
Timeframe: Baseline to endpoint (6 hour period)

,
InterventionUnits on a scale (Mean)
Baseline scoreChange from Baseline to Endpoint Score
Phenylephrine2.20-0.18
Placebo2.20-0.12

[back to top]

The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.

"To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo~The values for the nasal congestion score scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results." (NCT00276016)
Timeframe: Baseline to endpoint (6 hour period)

,
InterventionUnits on a scale (Mean)
BaselineEndpoint
Placebo2.20-0.12
Pseudoephedrine2.26-0.47

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SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3

The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact). (NCT00377403)
Timeframe: 4 days

InterventionUnits on a scale (Mean)
Intervention Arm1.12
Symptomatic Treatments Only1.14

[back to top]

Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry

The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC. (NCT00804687)
Timeframe: 2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

Interventionsquare centimeter*hour (cm^2*h) (Mean)
Placebo-0.682
JNJ-39220675-0.504
Pseudoephedrine-0.550

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Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)

The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry). (NCT00804687)
Timeframe: 2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period

Interventionunits on a scale * hours (Mean)
Placebo45.720
JNJ-3922067536.536
Pseudoephedrine43.195

[back to top]

Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1

The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline. (NCT00804687)
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

,,
Interventionsquare centimeter (cm^2) (Mean)
BaselineChange at Hour 1Change at Hour 2Change at Hour 3Change at Hour 4Change at Hour 5Change at Hour 6Change at Hour 7Change at Hour 8
JNJ-392206750.294-0.028-0.041-0.055-0.077-0.082-0.091-0.079-0.090
Placebo0.304-0.054-0.048-0.086-0.100-0.104-0.108-0.094-0.111
Pseudoephedrine0.312-0.0350.060-0.053-0.072-0.092-0.081-0.099-0.110

[back to top]

Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1

The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline. (NCT00804687)
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period

,,
Interventionunits on a scale (Mean)
Change at Hour 0.5Change at Hour 1Change at Hour 1.5Change at Hour 2Change at Hour 2.5Change at Hour 3.0Change at Hour 3.5Change at Hour 4Change at Hour 4.5Change at Hour 5Change at Hour 5.5Change at Hour 6Change at Hour 6.5Change at Hour 7Change at Hour 7.5Change at Hour 8
JNJ-392206751.42.23.23.94.14.74.95.45.35.35.45.65.76.16.16.5
Placebo2.73.54.15.05.65.85.66.16.46.56.66.97.07.07.07.4
Pseudoephedrine1.73.44.24.65.05.45.66.05.66.36.46.56.86.96.97.0

[back to top]

Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG

Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction. (NCT01028014)
Timeframe: 2 weeks

Interventionmicrovolts (Median)
Pseudoephedrine 120mg ER Daily-18
Solifenacin 5mg Daily10
Tamsulosin 0.4mg Daily11
Imipramine 25mg Daily-15
Cyclobenzaprine 10mg Daily12
Lactose Capsules, One Daily36

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Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry

Pressure Flowmetry was used to measure maximum urine flow rate (Qmax)before and after 2 weeks of therapy with one of 6 randomly assigned medications. A 300 cc bladder fill was performed through the catheter, the catheter was removed, and transurethral and transrectal pressure transducers were placed for the pressure flow study. Voiding was performed in the seated position. Information obtained for the database included Qmax, average flow rate, time to Qmax, detrusor pressure at maximum flow rate, voided volume, and a calculated post-void residual. (NCT01028014)
Timeframe: 2 weeks

Interventionmilliliters per second (Median)
Pseudoephedrine 120mg ER Daily-7.3
Solifenacin 5mg Daily5.0
Tamsulosin 0.4mg Daily-5.6
Imipramine 25mg Daily-6.6
Cyclobenzaprine 10mg Daily10.3
Lactose Capsules, One Daily10.4

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Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.

Current Perception Threshold testing was used to measure urethral sensation before and after 2 weeks of therapy with one of 6 randomly assigned medications. We performed CPT testing in the urethra using a Neurometer®, which is a constant current stimulator capable of delivering sine wave electrical stimuli at 3 frequencies (2000 Hz, 250 Hz and 5 Hz). At all 3 frequencies, the stimulus intensity was gradually increased until first perceived, and then decreased until no longer perceptible. CPT values were obtained using a semi-automated forced choice paradigm. (NCT01028014)
Timeframe: 2 weeks

InterventionMilliamps (Median)
Pseudoephedrine 120mg ER Daily0.06
Solifenacin 5mg Daily0.06
Tamsulosin 0.4mg Daily-0.8
Imipramine 25mg Daily-0.12
Cyclobenzaprine 10mg Daily0.0
Lactose Capsules, One Daily0.03

[back to top]

Antibiotic Sparing

Number of patients who received an antibiotic (NCT01202279)
Timeframe: Day 7

InterventionParticipants (Number)
Mucinex D89
Placebo121

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Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).

WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147. (NCT01202279)
Timeframe: Baseline and 7 Days

Interventionunits on a scale (Mean)
Mucinex D-14.2
Placebo-13.4

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Safety and Tolerability of the Syrup

Number of participants with adverse events. (NCT01586962)
Timeframe: 1 hour

InterventionParticipants (Number)
Upper Respiratory Infections9

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Subject Acceptability of the Syrup

"How do you like the warming sensation you have experienced for this product?~Possible responses are :~Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely" (NCT01586962)
Timeframe: 1 hour

InterventionParticipants (Number)
Upper Respiratory Infections39

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Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup

Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation (NCT01586962)
Timeframe: 1 minute

Interventionmm (Mean)
Upper Respiratory Infections34.2

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Area Under the Concentration-time Curve of Ibuprofen in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).

This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)143000
Test Product (T)141600

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Area Under the Concentration-time Curve of Pseudoephedrine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).

This endpoint calculates area under the concentration-time curve of Pseudoephedrine in plasma over the time interval from 0 extrapolated to infinity (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)2622
Test Product (T)2614

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Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Ibuprofen. (AUC0-tz)

This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point. (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

InterventionHour nano gram per milliliter (h*ng/mL) (Geometric Mean)
Reference Product (R)140500
Test Product (T)139300

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Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Pseudoephedrine (AUC0-tz).

This endpoint calculates area under the concentration-time curve of Pseudoephedrine in plasma over the time interval from 0 to the time of last quantifiable time point. (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)2547
Test Product (T)2540

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AUC0-∞ of R-Ibuprofen

This endpoint calculates area under the concentration-time curve of R-Ibuprofen in plasma over the time interval from 0 extrapolated to infinity (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)69420
Test Product (T)66740

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AUC0-∞ of S-Ibuprofen

This endpoint calculates area under the concentration-time curve of S-Ibuprofen in plasma over the time interval from 0 extrapolated to infinity (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)72270
Test Product (T)73460

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AUC0-tz of R-Ibuprofen

This endpoint calculates area under the concentration-time curve of R-Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point. (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)68520
Test Product (T)65760

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AUC0-tz of S-Ibuprofen

This endpoint calculates area under the concentration-time curve of S-Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point. (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)70290
Test Product (T)71610

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Cmax of R-Ibuprofen

This outcome is maximum measured concentration of the R-Ibuprofen in plasma (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionng/mL (Geometric Mean)
Reference Product (R)18630
Test Product (T)16910

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Cmax of S-Ibuprofen

This outcome is maximum measured concentration of the S-Ibuprofen in plasma (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionng/mL (Geometric Mean)
Reference Product (R)15050
Test Product (T)13020

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Maximum Concentration of Ibuprofen in Plasma (Cmax).

This outcome is maximum measured concentration of the Ibuprofen in plasma (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

InterventionNano gram per milliliter (ng/mL) (Geometric Mean)
Reference Product (R)33580
Test Product (T)29940

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Maximum Concentration of Pseudoephedrine in Plasma (Cmax).

This outcome is maximum measured concentration of the Pseudoephedrine in plasma (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionng/mL (Geometric Mean)
Reference Product (R)320.4
Test Product (T)327.4

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S/R-ibuprofen Ratio for AUC0-tz

AUC0-tz S-ibuprofen / AUC0-tz R-ibuprofen (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

InterventionRatio (Geometric Mean)
Reference Product (R)1.026
Test Product (T)1.089

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