At a glance
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An Open-Label Drug-Drug Interaction Study to Investigate the Effects of Steady State Quinine on the Single-Dose Pharmacokinetics of Rosiglitazone Maleate in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Rosiglitazone 4 mg Tablets and Quinine Sulfate 324 mg Capsules for Healthy. Completed, enrolled 23 participants across 1 site.
Detailed Summary
Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine sulfate at steady-state on the pharmacokinetics of single-dose rosiglitazone in healthy adult subjects.
Study Details
Timeline
Interventions
Rosiglitazone 4 mg tablet administered as a single oral dose on the morning of Day 1.
Co-administered single oral doses of rosiglitazone 4 mg (1 x 4 mg tablet) and quinine sulfate 648 mg (2 x 324 mg capsules) on the morning of Day 7.
Co-administered single oral doses of rosiglitazone 4 mg (1 x 4 mg tablet) and quinine sulfate 648 mg (2 x 324 mg capsules) on the morning of Day 7.