Drug-Drug Interaction Study of Qualaquin and Midazolam

Phase 1 Completed 24 enrolled Mutual Pharmaceutical Company, Inc.

Non-randomizedSingle-groupOpen-labelBasic science

Summary

This is an open label non-randomized single sequence, single group two way drug interaction study in healthy adult volunteers to determine the extent to which quinine, an inducer of cytochrome p450 CYP 3A4, affects the pharmacokinetics of midazolam, an accepted probe drug for CYP 3A4. The study will also determine the extent to which midazolam affects the pharmacokinetics of quinine.

Timeline

Start: 2007-03
Primary completion: 2007-03
Completion: 2007-03

Publications

Terkeltaub RA, Furst DE, Digiacinto JL, Kook KA, Davis MW. Novel evidence-based colchicine dose-reduction algorithm to predict and prevent colchicine toxicity in the presence of cytochrome P450 3A4/P-glycoprotein inhibitors. Arthritis Rheum. 2011 Aug;63(8):2226-37. doi: 10.1002/art.30389.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	2 mg	Oral
Subject	Quinine	Small molecule	324 mg	Oral

Indications

No indication recorded.