Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mutual Pharmaceutical Company, Inc.
• Treatments: Quinine

Criteria

Inclusion Criteria:

• Healthy nonsmoking adults with hemoglobin at least 12 g/dl. Males at least 52 kg, females at least 45kg with body mass index in the normal range, females must be chemically or surgically sterile or postmenopausal (amenorrhea at least 2years)

Exclusion Criteria:

• Pregnant or lactating

• Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) Recent (1-year) history or evidence of alcoholism or drug abuse History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease, myasthenia gravis, optic neuritis or Glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Prolonged corrected QT interval(QTc) on Electrocardiogram(EKG) at screening -males >430 msec, females >450 msec.

PR interval on EKG >200 msec at screening or prior to dose in either dosing period

• Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 30 days prior to the first dose and throughout the study