Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

Phase 1 Completed 28 enrolled CrystalGenomics, Inc.

RandomizedCrossoverOpen-labelTreatment

Summary

This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.

Timeline

Start: 2009-10
Primary completion: 2010-03
Completion: 2010-12

Publications

Youn Choi H, Jin SJ, Jung JA, Kim UJ, Ko YJ, Noh YH, Bae KS, Lim HS. Effects of ketoconazole on the pharmacokinetic properties of CG100649, a novel NSAID: a randomized, open-label crossover study in healthy Korean male volunteers. Clin Ther. 2014 Jan 1;36(1):115-25. doi: 10.1016/j.clinthera.2013.12.004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketoconazole	Small molecule	400 mg	Oral
Subject	Polmacoxib	Other / unclassified	6 mg	Oral

Indications

No indication recorded.