Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin - Full Text View

Sponsored by:	Mutual Pharmaceutical Company, Inc.
Information provided by:	Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:	NCT00785980

Purpose

Ciprofloxacin is a moderate to severe inhibitor of the activity of cytochrome p450 CYP 1A2, 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.

Condition	Intervention	Phase
Healthy	Drug: quinine sulfate Drug: quinine sulfate plus ciprofloxacin	Phase I

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Quinine Quinine bisulfate Quinine hydrochloride Quinine sulfate BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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

Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:

To determine the effect of multiple doses of ciprofloxacin on the pharmacokinetics of quinine sulfate in healthy adult subjects [ Time Frame: days 1 and 8 - 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability of quinine sulfate administered alone and in combination with ciprofloxacin [ Time Frame: days 1 and 8 - 11 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	September 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 quinine sulfate alone	Drug: quinine sulfate baseline quinine sulfate pharmacokinetics
2: Experimental quinine sulfate kinetics in the presence of ciprofloxacin	Drug: quinine sulfate plus ciprofloxacin quinine sulfate kinetics in the presence of ciprofloxacin

Detailed Description:

Ciprofloxacin is a moderate to severe inhibitor of the activity of cytochrome p450 CYP 1A2, one of the enzymes responsible for the metabolism of quinine sulfate. This study will evaluate the extent to which ciprofloxacin-related inhibition of CYP1A2 affects the pharmacokinetics of quinine sulfate. This study will compare the pharmacokinetics of quinine sulfate alone to quinine sulfate after multiple doses of ciprofloxacin. In this non-blinded crossover study 24 normal healthy, non-smoking, non-obese (BMI 18 - 32) male and female volunteers will serve as their own controls. On day 1 after a minimum overnight fast of 10 hours, study participants will receive a single dose of 648mg of quinine sulfate. Blood will be drawn at times sufficient to adequately define the baseline concentration time curve for this drug. Following a 7 day washout period, volunteers will take ciprofloxacin 500mg twice daily for a total of four consecutive days (Days 8-11). On the morning of day 11 after a 10 hour overnight fast, study participants will receive 648mg of quinine sulfate in addition to 500mg ciprofloxacin. Again blood will be drawn at times sufficient to adequately define the concentration time curve for quinine sulfate in the presence of ciprofloxacin. The two concentration time curves will be compared to determine the extent of the drug-drug interaction.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy non-smoking adult volunteers (M & F), 18 to 45 years of age, inclusive with BMI between 18 and 32 inclusive.

Exclusion Criteria:

Subjects with history or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or an active sexually transmitted disease . Subjects with recent (2-year) history or evidence of alcoholism or drug abuse. Subjects who have used any drugs or substances known to inhibit or induce cytochrome P450 (CYP) enzymes and/or P-glycoprotein within 28 days prior to the first dose and throughout the study. Subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV). Subjects who are pregnant or lactating or have known allergies to quinine sulfate, mefloquine, quinidine or ciprofloxacin and other fluoroquinolones

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785980

Sponsors and Collaborators

Mutual Pharmaceutical Company, Inc.

Investigators

Principal Investigator:

Anthony R Godfrey, PharmD

PRACS Institute, Ltd.

More Information

Responsible Party:	Mutual Pharmaceutical Company, Inc. ( Vice President Branded Products and Medical Affairs )
Study ID Numbers:	MPC-001-08-1027
Study First Received:	November 3, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00785980
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mutual Pharmaceutical Company, Inc.:

quinine sulfate
ciprofloxacin
drug interactions
cytochrome p450
male

female
adult
pharmacokinetics
drug interactions

Study placed in the following topic categories:

Ciprofloxacin
Quinine
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Neuromuscular Agents
Pharmacologic Actions
Antimalarials
Antiparasitic Agents

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Muscle Relaxants, Central
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009