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”

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.

Study Type: Interventional

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

Study Primary Completion Date: October 2008

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.

Intervention(s) in this Clinical Trial

• Drug: quinine sulfate
  • baseline quinine sulfate pharmacokinetics
• Drug: quinine sulfate plus ciprofloxacin
  • quinine sulfate kinetics in the presence of ciprofloxacin

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • quinine sulfate alone
• Experimental: 2
  • quinine sulfate kinetics in the presence of ciprofloxacin

Primary 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
    Safety Issue?: No

Secondary Measures

• To assess the safety and tolerability of quinine sulfate administered alone and in combination with ciprofloxacin
  • Time Frame: days 1 and 8 - 11
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mutual Pharmaceutical Company, Inc.

Overall Clinical Trial Officials and Contacts

Anthony R Godfrey, PharmD Principal Investigator PRACS Institute, Ltd.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00785980

Study ID Number: MPC-001-08-1027

ClinicalTrials.gov Identifier: NCT00785980

Health Authority: United States: Food and Drug Administration

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