Phase 1
N=23
Drug-Drug Interaction Study Between Quinine Sulfate and Rosiglitazone
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00785213 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: Primary: Maximum Plasma Concentration (Cmax) of Rosiglitazone — 0.41; 0.43 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Rosiglitazone 4 mg Tablets (Drug); Quinine Sulfate 324 mg Capsules (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mutual Pharmaceutical Company, Inc.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of Rosiglitazone |
0.41; 0.43 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] |
1.96; 2.07 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] |
1.99; 2.10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy adults 18-45 years of age
- Non-smoking
- Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
- Body mass index (BMI) less than or equal to 32
- Medically healthy on the basis of medical history and physical examination
- Hemoglobin > or = to 11.5g/dL
- Completion of the screening process within 28 days prior to dosing
- Provision of voluntary written informed consent
Exclusion Criteria
- Recent participation (within 28 days) in other research studies
- Recent significant blood donation or plasma donation
- Pregnant or lactating
- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
- Recent (2-year) history or evidence of alcoholism or drug abuse
- History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
- Drug allergies to quinine sulfate or rosiglitazone
Data sourced from ClinicalTrials.gov (NCT00785213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.