Phase 1
N=24
Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00785980 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2009
Primary outcome: Primary: Maximum Plasma Concentration(Cmax) — 4,240.65; 4,521.20 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Quinine Sulfate Capsules 324 mg (Drug); Ciprofloxacin 500 mg (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) |
4,240.65; 4,521.20 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] |
63,415.67; 68,572.17 | — |
| PRIMARY Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]. |
67,694.99; 77,439.24 | — |
Summary
Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes responsible for the metabolism of quinine. This study will evaluate the effect of ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate.
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)between 18 and 32
- Medically healthy on the basis of medical history and physical examination
- Hemoglobin > or = to 11.5 g/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 mefloquine or quinidine
Data sourced from ClinicalTrials.gov (NCT00785980). 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.