CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 27 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/NCT00727272
NCT00727272Phase 1Completed

A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions

Mutual Pharmaceutical Company, Inc.·interventional·Posted Aug 1, 2008·Updated Jan 20, 2010

In Brief

A Phase 1 clinical trial evaluating Quinine Sulfate Capsules 324 mg and Quinine Sulphate Tablets 300 mg for Healthy. Completed, enrolled 27 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine Sulphate 300 mg tablets, manufactured by the Government Pharmaceutical Organization, Bangkok Metropolis, Thailand, after single oral dose administration under fasting conditions. An additional purpose of this study is to evaluate the effect of food on the Mutual Pharmaceutical Company product.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 1, 2008
Enrollment StartFeb 1, 2004
Primary CompletionMar 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.9 years ago

Interventions

Quinine Sulfate Capsules 324 mgdrug

One 324 mg capsule administered after an overnight fast of at least 10 hours.

Quinine Sulphate Tablets 300 mgdrug

One 300 mg tablet administered after an overnight fast of at least 10 hours.

Quinine Sulfate Capsules 324 mgdrug

One 324 mg capsule administered thirty minutes after the initiation of a standardized, high-fat breakfast.