Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): Quinine Sulfate Capsules 324 mg; Ciprofloxacin 500 mg; Quinine Sulfate Capsules 324 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of quinine sulfate (2 x 324 mg capsules) administered on the morning of Day 1 after an overnight fast of at least 10 hours.; A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 11 after an overnight fast of at least 10 hours.; A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 11 after an overnight fast of at least 10 hours.
Other intervention name(s): Qualaquin®; Cipro®; Qualaquin®
Intervention MeSH terms: Ciprofloxacin; Quinine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: quinine sulfate; ciprofloxacin; drug interactions; cytochrome p450; male; female; adult; pharmacokinetics