Compounds > fomepizole
Page last updated: 2024-10-27

fomepizole and Flushing

fomepizole has been researched along with Flushing in 2 studies

Fomepizole: A pyrazole and competitive inhibitor of ALCOHOL DEHYDROGENASE that is used for the treatment of poisoning by ETHYLENE GLYCOL or METHANOL.
fomepizole : A member of the class of pyrazoles that is 1H-pyrazole substituted by a methyl group at position 4.

Flushing: A transient reddening of the face that may be due to fever, certain drugs, exertion, or stress.

Research Excerpts

ExcerptRelevanceReference
"Alcohol-sensitive Japanese subjects with facial flushing and an increase in heart rate during ethanol intoxication exhibited marked individual variation in accumulation of acetaldehyde."3.67Suppression of acetaldehyde accumulation by 4-methylpyrazole in alcohol-hypersensitive Japanese. ( Inoue, K; Kera, Y; Kiriyama, T; Komura, S, 1985)
"Fomepizole 15 mg/kg was given with improvement within 1."1.38Fomepizole for severe disulfiram-ethanol reactions. ( Monte, AA; Sande, M; Thompson, D, 2012)

Research

Studies (2)

TimeframeStudies, this research(%)All Research%
pre-19901 (50.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's1 (50.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Sande, M1
Thompson, D1
Monte, AA1
Inoue, K1
Kera, Y1
Kiriyama, T1
Komura, S1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase IIa, Prospective, Randomized, Blinded, Intra-Subject Controlled, Single Dose, Dose Escalation Study of Antizol® for Mitigation of Acetaldehyde Related Toxicity in Human Subjects With Symptoms of Inborn Altered Ethanol Metabolism With Concomitant E[NCT00661141]Phase 232 participants (Actual)Interventional2008-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Pharmacokinetics (PK) of 4-MP: Maximum Plasma Concentration (Cmax)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionng/mL (Mean)
1.0 mg/kg Antizol Followed by Ethanol2386
Ethanol Followed by 1.0 mg/kg Antizol1358
3.0 mg/kg Antizol Followed by Ethanol5605
Ethanol Followed by 3.0 mg/kg Antizol4680
5.0 mg/kg Antizol Followed by Ethanol8623

PK of 4-MP: Apparent Clearance (CL/F)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

InterventionL/hr (Mean)
1.0 mg/kg Antizol Followed by Ethanol6.70
Ethanol Followed by 1.0 mg/kg Antizol8.23
3.0 mg/kg Antizol Followed by Ethanol3.15
Ethanol Followed by 3.0 mg/kg Antizol2.99
5.0 mg/kg Antizol Followed by Ethanol2.35

PK of 4-MP: Apparent Volume of Distribution During Terminal Phase (Vz/F)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

InterventionLiters (Mean)
1.0 mg/kg Antizol Followed by Ethanol26.3
Ethanol Followed by 1.0 mg/kg Antizol24.7
3.0 mg/kg Antizol Followed by Ethanol24.4
Ethanol Followed by 3.0 mg/kg Antizol24.9
5.0 mg/kg Antizol Followed by Ethanol24.7

PK of 4-MP: Area Under the Plasma Concentration-Time Curve (AUC), Calculated to the Last Measured Concentration (AUC[0-t])

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionng*hr/mL (Mean)
1.0 mg/kg Antizol Followed by Ethanol13804
Ethanol Followed by 1.0 mg/kg Antizol7409
3.0 mg/kg Antizol Followed by Ethanol44942
Ethanol Followed by 3.0 mg/kg Antizol34310
5.0 mg/kg Antizol Followed by Ethanol109298

PK of 4-MP: AUC, From Time 0 Extrapolated to Infinite Time (AUC[0-∞])

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionng*hr/mL (Mean)
1.0 mg/kg Antizol Followed by Ethanol11035
Ethanol Followed by 1.0 mg/kg Antizol7627
3.0 mg/kg Antizol Followed by Ethanol55452
Ethanol Followed by 3.0 mg/kg Antizol57028
5.0 mg/kg Antizol Followed by Ethanol136871

PK of 4-MP: DN AUC(0-∞)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Intervention(ng*hr/mL)/mg (Mean)
1.0 mg/kg Antizol Followed by Ethanol149
Ethanol Followed by 1.0 mg/kg Antizol122
3.0 mg/kg Antizol Followed by Ethanol317
Ethanol Followed by 3.0 mg/kg Antizol334
5.0 mg/kg Antizol Followed by Ethanol460

PK of 4-MP: DN AUC(0-t)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Intervention(ng*hr/mL)/mg (Mean)
1.0 mg/kg Antizol Followed by Ethanol223
Ethanol Followed by 1.0 mg/kg Antizol103
3.0 mg/kg Antizol Followed by Ethanol231
Ethanol Followed by 3.0 mg/kg Antizol204
5.0 mg/kg Antizol Followed by Ethanol378

PK of 4-MP: Dose-Normalized (DN) Cmax

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Intervention(ng/mL)/mg (Mean)
1.0 mg/kg Antizol Followed by Ethanol38.3
Ethanol Followed by 1.0 mg/kg Antizol18.9
3.0 mg/kg Antizol Followed by Ethanol27.6
Ethanol Followed by 3.0 mg/kg Antizol28.0
5.0 mg/kg Antizol Followed by Ethanol30.2

PK of 4-MP: Half-Life (T1/2)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionhours (Mean)
1.0 mg/kg Antizol Followed by Ethanol2.72
Ethanol Followed by 1.0 mg/kg Antizol3.11
3.0 mg/kg Antizol Followed by Ethanol5.37
Ethanol Followed by 3.0 mg/kg Antizol5.76
5.0 mg/kg Antizol Followed by Ethanol9.26

PK of 4-MP: Percentage of AUC0-∞ Obtained by Extrapolation (AUC%Extrap)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionpercentage (Mean)
1.0 mg/kg Antizol Followed by Ethanol16.8
Ethanol Followed by 1.0 mg/kg Antizol13.0
3.0 mg/kg Antizol Followed by Ethanol3.31
Ethanol Followed by 3.0 mg/kg Antizol4.37
5.0 mg/kg Antizol Followed by Ethanol13.2

PK of 4-MP: Time to Cmax (Tmax)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionhours (Median)
1.0 mg/kg Antizol Followed by Ethanol1.00
Ethanol Followed by 1.0 mg/kg Antizol2.50
3.0 mg/kg Antizol Followed by Ethanol0.667
Ethanol Followed by 3.0 mg/kg Antizol1.48
5.0 mg/kg Antizol Followed by Ethanol1.00

PK of Acetaldehyde: AUC(0-∞)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

InterventionµM*hr (Mean)
1.0 mg/kg Antizol Followed by Ethanol234
Ethanol Followed by 1.0 mg/kg Antizol154
3.0 mg/kg Antizol Followed by Ethanol297
Ethanol Followed by 3.0 mg/kg Antizol302
5.0 mg/kg Antizol Followed by Ethanol188
Placebo Followed by Ethanol205
Ethanol Followed by Placebo227

PK of Acetaldehyde: AUC(0-t)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

InterventionµM*hr (Mean)
1.0 mg/kg Antizol Followed by Ethanol178
Ethanol Followed by 1.0 mg/kg Antizol118
3.0 mg/kg Antizol Followed by Ethanol155
Ethanol Followed by 3.0 mg/kg Antizol167
5.0 mg/kg Antizol Followed by Ethanol128
Placebo Followed by Ethanol163
Ethanol Followed by Placebo139

PK of Acetaldehyde: AUC%Extrap

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionpercentage (Mean)
1.0 mg/kg Antizol Followed by Ethanol19.0
Ethanol Followed by 1.0 mg/kg Antizol18.8
3.0 mg/kg Antizol Followed by Ethanol13.1
Ethanol Followed by 3.0 mg/kg Antizol9.78
5.0 mg/kg Antizol Followed by Ethanol24.7
Placebo Followed by Ethanol13.7
Ethanol Followed by Placebo14.5

PK of Acetaldehyde: Cmax

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

InterventionµM (Mean)
1.0 mg/kg Antizol Followed by Ethanol59.6
Ethanol Followed by 1.0 mg/kg Antizol37.6
3.0 mg/kg Antizol Followed by Ethanol50.9
Ethanol Followed by 3.0 mg/kg Antizol55.9
5.0 mg/kg Antizol Followed by Ethanol40.0
Placebo Followed by Ethanol60.3
Ethanol Followed by Placebo42.7

PK of Acetaldehyde: DN AUC(0-∞)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

InterventionµM*hr/mg (Mean)
1.0 mg/kg Antizol Followed by Ethanol0.00682
Ethanol Followed by 1.0 mg/kg Antizol0.00432
3.0 mg/kg Antizol Followed by Ethanol0.00929
Ethanol Followed by 3.0 mg/kg Antizol0.0105
5.0 mg/kg Antizol Followed by Ethanol0.00626
Placebo Followed by Ethanol0.00616
Ethanol Followed by Placebo0.00752

PK of Acetaldehyde: DN AUC(0-t)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

InterventionµM*hr/mg (Mean)
1.0 mg/kg Antizol Followed by Ethanol0.00547
Ethanol Followed by 1.0 mg/kg Antizol0.00329
3.0 mg/kg Antizol Followed by Ethanol0.00470
Ethanol Followed by 3.0 mg/kg Antizol0.00597
5.0 mg/kg Antizol Followed by Ethanol0.00439
Placebo Followed by Ethanol0.00521
Ethanol Followed by Placebo0.00455

PK of Acetaldehyde: DN Cmax

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

InterventionµM/mg (Mean)
1.0 mg/kg Antizol Followed by Ethanol0.00181
Ethanol Followed by 1.0 mg/kg Antizol0.00104
3.0 mg/kg Antizol Followed by Ethanol0.00157
Ethanol Followed by 3.0 mg/kg Antizol0.00201
5.0 mg/kg Antizol Followed by Ethanol0.00138
Placebo Followed by Ethanol0.00193
Ethanol Followed by Placebo0.00141

PK of Acetaldehyde: T1/2

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionhours (Mean)
1.0 mg/kg Antizol Followed by Ethanol3.14
Ethanol Followed by 1.0 mg/kg Antizol3.08
3.0 mg/kg Antizol Followed by Ethanol2.48
Ethanol Followed by 3.0 mg/kg Antizol1.72
5.0 mg/kg Antizol Followed by Ethanol3.45
Placebo Followed by Ethanol2.39
Ethanol Followed by Placebo2.09

PK of Acetaldehyde: Tmax

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionhours (Median)
1.0 mg/kg Antizol Followed by Ethanol0.500
Ethanol Followed by 1.0 mg/kg Antizol0.650
3.0 mg/kg Antizol Followed by Ethanol1.00
Ethanol Followed by 3.0 mg/kg Antizol1.33
5.0 mg/kg Antizol Followed by Ethanol0.500
Placebo Followed by Ethanol0.500
Ethanol Followed by Placebo0.925

PK of Ethanol: AUC(0-∞)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionmg*hr/mL (Mean)
1.0 mg/kg Antizol Followed by Ethanol245
Ethanol Followed by 1.0 mg/kg Antizol263
3.0 mg/kg Antizol Followed by Ethanol237
Ethanol Followed by 3.0 mg/kg Antizol215
5.0 mg/kg Antizol Followed by Ethanol271
Placebo Followed by Ethanol214
Ethanol Followed by Placebo198

PK of Ethanol: AUC(0-t)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionmg*hr/dL (Mean)
1.0 mg/kg Antizol Followed by Ethanol209
Ethanol Followed by 1.0 mg/kg Antizol209
3.0 mg/kg Antizol Followed by Ethanol205
Ethanol Followed by 3.0 mg/kg Antizol135
5.0 mg/kg Antizol Followed by Ethanol231
Placebo Followed by Ethanol157
Ethanol Followed by Placebo152

PK of Ethanol: AUC%Extrap

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionpercentage (Mean)
1.0 mg/kg Antizol Followed by Ethanol14.7
Ethanol Followed by 1.0 mg/kg Antizol20.5
3.0 mg/kg Antizol Followed by Ethanol13.2
Ethanol Followed by 3.0 mg/kg Antizol20.0
5.0 mg/kg Antizol Followed by Ethanol12.1
Placebo Followed by Ethanol13.4
Ethanol Followed by Placebo13.9

PK of Ethanol: CL/F

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

InterventiondL/hr (Mean)
1.0 mg/kg Antizol Followed by Ethanol140
Ethanol Followed by 1.0 mg/kg Antizol138
3.0 mg/kg Antizol Followed by Ethanol142
Ethanol Followed by 3.0 mg/kg Antizol131
5.0 mg/kg Antizol Followed by Ethanol112
Placebo Followed by Ethanol159
Ethanol Followed by Placebo167

PK of Ethanol: Cmax

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionmg/dL (Mean)
1.0 mg/kg Antizol Followed by Ethanol62.7
Ethanol Followed by 1.0 mg/kg Antizol70.3
3.0 mg/kg Antizol Followed by Ethanol80.5
Ethanol Followed by 3.0 mg/kg Antizol43.3
5.0 mg/kg Antizol Followed by Ethanol74.9
Placebo Followed by Ethanol59.3
Ethanol Followed by Placebo55.1

PK of Ethanol: DN AUC(0-∞)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Intervention(mg*hr/dL)/mg (Mean)
1.0 mg/kg Antizol Followed by Ethanol0.00760
Ethanol Followed by 1.0 mg/kg Antizol0.00731
3.0 mg/kg Antizol Followed by Ethanol0.00705
Ethanol Followed by 3.0 mg/kg Antizol0.00768
5.0 mg/kg Antizol Followed by Ethanol0.00917
Placebo Followed by Ethanol0.00681
Ethanol Followed by Placebo0.00617

PK of Ethanol: DN AUC(0-t)

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Intervention(mg*hr/dL)/mg (Mean)
1.0 mg/kg Antizol Followed by Ethanol0.00648
Ethanol Followed by 1.0 mg/kg Antizol0.00585
3.0 mg/kg Antizol Followed by Ethanol0.00613
Ethanol Followed by 3.0 mg/kg Antizol0.00483
5.0 mg/kg Antizol Followed by Ethanol0.00791
Placebo Followed by Ethanol0.00508
Ethanol Followed by Placebo0.00476

PK of Ethanol: DN Cmax

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Intervention(mg/dL)/mg (Mean)
1.0 mg/kg Antizol Followed by Ethanol0.00195
Ethanol Followed by 1.0 mg/kg Antizol0.00198
3.0 mg/kg Antizol Followed by Ethanol0.00243
Ethanol Followed by 3.0 mg/kg Antizol0.00155
5.0 mg/kg Antizol Followed by Ethanol0.00261
Placebo Followed by Ethanol0.00193
Ethanol Followed by Placebo0.00175

PK of Ethanol: T1/2

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionhours (Mean)
1.0 mg/kg Antizol Followed by Ethanol1.51
Ethanol Followed by 1.0 mg/kg Antizol1.95
3.0 mg/kg Antizol Followed by Ethanol1.43
Ethanol Followed by 3.0 mg/kg Antizol1.78
5.0 mg/kg Antizol Followed by Ethanol1.67
Placebo Followed by Ethanol1.45
Ethanol Followed by Placebo1.32

PK of Ethanol: Tmax

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

Interventionhours (Median)
1.0 mg/kg Antizol Followed by Ethanol1.50
Ethanol Followed by 1.0 mg/kg Antizol0.833
3.0 mg/kg Antizol Followed by Ethanol0.500
Ethanol Followed by 3.0 mg/kg Antizol1.42
5.0 mg/kg Antizol Followed by Ethanol0.500
Placebo Followed by Ethanol0.500
Ethanol Followed by Placebo1.01

PK of Ethanol: Vz/F

(NCT00661141)
Timeframe: Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment

InterventiondL (Mean)
1.0 mg/kg Antizol Followed by Ethanol297
Ethanol Followed by 1.0 mg/kg Antizol387
3.0 mg/kg Antizol Followed by Ethanol295
Ethanol Followed by 3.0 mg/kg Antizol330
5.0 mg/kg Antizol Followed by Ethanol242
Placebo Followed by Ethanol287
Ethanol Followed by Placebo321

Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation

AEs were collected to evaluate the safety and tolerability of oral Antizol with concomitant ethanol administration in particitpants with symptoms of acetaldehyde toxicity associated with altered ethanol metabolism. AE: any untoward medical event that occurs following the first administration of study medication until the study participant's last study visit, whether or not the event is considered drug related. SAE: an event that meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of an exposed subject; is medically significant or an important medical event as assessed by investigator or sponsor; is, in the opinion of the investigator, an important medical event. (NCT00661141)
Timeframe: Study Day 0 through Study Visit Day 7

,,,,
InterventionParticipants (Count of Participants)
Any AEMild AEModerate AESevere AELife-Threatening/Disabling AEDeathPossibly or Probably Related AEAE Leading to Study DiscontinuationSerious AE
Antizol 1.0 mg/kg131320001300
Antizol 3.0 mg/kg660000600
Antizol 5.0 mg/kg880000500
Overall282870002700
Pooled Placebo211950001800

Other Studies

2 other studies available for fomepizole and Flushing

ArticleYear
Fomepizole for severe disulfiram-ethanol reactions.
    The American journal of emergency medicine, 2012, Volume: 30, Issue:1

    Topics: Acetaldehyde; Alcohol Dehydrogenase; Antidotes; Disulfiram; Drug Interactions; Ethanol; Female; Flus

2012
Suppression of acetaldehyde accumulation by 4-methylpyrazole in alcohol-hypersensitive Japanese.
    Japanese journal of pharmacology, 1985, Volume: 38, Issue:1

    Topics: Acetaldehyde; Adult; Alcoholic Intoxication; Flushing; Fomepizole; Heart; Heart Rate; Humans; Male;

1985