Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin
Information source: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Quinine Sulfate Capsules 324 mg (Drug); Ciprofloxacin 500 mg (Drug); Quinine Sulfate Capsules 324 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mutual Pharmaceutical Company, Inc. Official(s) and/or principal investigator(s): Anthony R Godfrey, PharmD, Principal Investigator, Affiliation: PRACS Institute, Ltd.
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.
Clinical Details
Official title: A One-Directional, Open-Label Drug Interaction Study to Investigate the Effects of Multiple-Dose Ciprofloxacin HCl on the Single-Dose Pharmacokinetics of Quinine in Healthy Volunteers
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Maximum Plasma Concentration(Cmax)Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].
Detailed description:
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. In
the morning on study Day 1 after a fast of at least 10 hours, twenty-four healthy,
non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 will be
given one oral dose of quinine sulfate (2 x 324 mg capsules). Fasting will continue for 4
hours after the dose. Blood samples will be drawn from all participants before dosing and
for 36 hours post-dose at times sufficient to adequately define the pharmacokinetics of
quinine sulfate. A 7-day washout period will be completed after the first dose of quinine
sulfate on Day 1. Beginning at 07: 45 am on Day 8 and continuing through Day 10, all subjects
will return to the clinic for non-confined dosing of ciprofloxacin (1 x 500 mg tablet) every
12 hours. Administered ciprofloxacin doses on these days will not be in a fasted state. At
07: 45 am on Day 11 after a fast of at least 10 hours, all study participants will receive a
co-administered single oral dose of quinine sulfate (2 x 324 mg capsules) and ciprofloxacin
(1 x 500 mg tablet). A final dose of ciprofloxacin (1 x 500 mg tablet) will be administered
12 hours later. Blood samples will be drawn from all participants before dosing and for 36
hours post-dose at times sufficient to adequately define the pharmacokinetics of quinine
sulfate. Fasting will continue for 4 hours following the co-administered dose of quinine
sulfate and ciprofloxacin. A further goal of this study is to evaluate the safety and
tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout
participation in the study for adverse reactions to the study drug and/or procedures. Seated
blood pressure and pulse will be measured pre-dose and at 1, 2 and 3 hours post-dose on Days
1 and 11. An electrocardiogram (ECG) will be done pre-dose and at 1, 2 and 4 hours
post-dose on Days 1 and 11. All adverse events whether elicited by query, spontaneously
reported, or observed by clinic staff will be evaluated by the Investigator and reported in
the subject's case report form.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
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Starting date: September 2008
Last updated: July 31, 2012
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