NCT00806078

Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding

A Comparison of the Bioavailability of Quinine Sulfate Capsules Following a 648 mg Dose When Mixed in Chocolate Pudding Relative to That With Intact Capsules in Healthy Adults Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Mutual Pharmaceutical Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with 120 ml of chocolate pudding relative to the same dose given as two intact capsules.

Detailed description

Prior studies have shown that intact quinine sulfate capsules can be taken without regard for food. This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648mg(2 x 324 mg capsules) when opened and mixed with 120 ml of chocolate pudding relative to the same dose given as two intact capsules. Eighteen healthy adult subjects will be enrolled. Following a fast of at least 10 hours subjects will be randomized to receive either 648 mg of quinine sulfate as the intact capsules or opened mixed in 120ml of chocolate pudding. Following a washout period of at least 7 days all subjects will be given the alternate dose under similar conditions. Following each dose, blood samples will be collected at times sufficient to determine the difference in bioavailability (if any) between the two methods of drug administration. In addition patients will be monitored for any adverse events including Electrocardiogram (EKG) changes (at baseline and 4 hours after each dose).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	quinine sulfate	2 x 324 mg capsules (648 mg)
DRUG	quinine sulfate	2 x 324 mg capsules (648 mg)

Timeline

• Start date: 2007-07-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2008-12-10
• Last updated: 2012-08-31
• Results posted: 2009-07-08

Locations

1 site across 1 country: Canada