Status:
COMPLETED
Drug-Drug Interaction Study Between Quinine Sulfate and Rosiglitazone
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Collaborating Sponsors:
Cetero Research, San Antonio
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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-...
Detailed Description
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00785213
Start Date
September 1 2008
End Date
October 1 2008
Last Update
August 7 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cetero Research
East Grand Forks, Minnesota, United States, 56721