CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Quinine Sulfate Capsules 324 mg +2 moredrug
Likely dose
Quinine Sulfate Capsules 324 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00785980
NCT00785980Phase 1Completed
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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

Mutual Pharmaceutical Company, Inc.·interventional·Posted Nov 5, 2008·Updated Aug 7, 2012

In Brief

A Phase 1 clinical trial evaluating Quinine Sulfate Capsules 324 mg and Ciprofloxacin 500 mg for Healthy. Completed, enrolled 24 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 5, 2008
Enrollment StartSep 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.7 years ago

Interventions

Quinine Sulfate Capsules 324 mgdrug

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.

Ciprofloxacin 500 mgdrug

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.

Quinine Sulfate Capsules 324 mgdrug

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.