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

NCT00727272 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2010-01-20

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Quinine Sulfate Capsules 324 mg

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

DRUG

Quinine Sulphate Tablets 300 mg

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

DRUG

Quinine Sulfate Capsules 324 mg

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

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • James D Carlson, Pharm.D. · PRACS

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2004-03-31
Completion
2004-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00727272 on ClinicalTrials.gov