Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

Phase 1 Completed 24 enrolled LG Life Sciences

RandomizedParallel-groupOpen-labelTreatment

Summary

A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male Volunteers.

Timeline

Start: 2011-01
Primary completion: 2011-03
Completion: 2011-03

Publications

Noh YH, Lim HS, Jin SJ, Kim MJ, Kim YH, Sung HR, Choi HY, Bae KS. Effects of ketoconazole and rifampicin on the pharmacokinetics of gemigliptin, a dipeptidyl peptidase-IV inhibitor: a crossover drug-drug interaction study in healthy male Korean volunteers. Clin Ther. 2012 May;34(5):1182-94. doi: 10.1016/j.clinthera.2012.04.001. Epub 2012 Apr 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketoconazole	Small molecule	400 mg	Oral
Subject	Rifampin	Small molecule	600 mg	Oral

Indications

No indication recorded.