lc15-0444 has been researched along with Renal-Insufficiency* in 1 studies
1 other study(ies) available for lc15-0444 and Renal-Insufficiency
Article | Year |
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Effect of renal impairment and haemodialysis on the pharmacokinetics of gemigliptin (LC15-0444).
This study evaluated the effects of renal impairment (RI) and haemodialysis (HD) on the pharmacokinetics of gemigliptin, a novel dipeptidyl peptidase-4 (DPP-4) inhibitor. After a 100 mg administration to subjects with normal renal function (n = 23) or RI (n = 24), plasma, urine or dialysate samples were analysed. Control subjects were matched to patients based on age, gender and body mass index. Patients with mild, moderate, severe RI and end-stage renal disease (ESRD) showed 1.20, 2.04, 1.50 and 1.66-fold (1.10, 1.49, 1.22 and 1.21-fold) increase of mean area under the time-plasma concentration curve from 0 to infinity (AUCinf) [maximum plasma concentration (Cmax)] of gemigliptin, respectively. Pharmacokinetics of gemigliptin was comparable between HD and non-HD periods in ESRD patients. Less than 4% of the dose was removed by 4 h HD. RI appeared to have modest effect on the gemigliptin disposition. No dose adjustment in patients with RI is proposed on the basis of exposure-response relationship. Impact of HD on the removal of gemigliptin was negligible. Topics: Area Under Curve; Creatinine; Dipeptidyl-Peptidase IV Inhibitors; Female; Humans; Male; Metabolic Clearance Rate; Piperidones; Pyrimidines; Renal Dialysis; Renal Insufficiency | 2014 |