Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding

NCT ID: NCT00806078

Last Updated: 2012-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2007-08-31

Brief 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

Keywords

Healthy; Bioequivalence; Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

Single dose intact capsules 2 x 324 mg

Group Type: EXPERIMENTAL

quinine sulfate

Intervention Type: DRUG

2 x 324 mg capsules (648 mg)

2

Single dose contents of two capsules (2 x 324 mg) opened and mixed in 120 mL of chocolate pudding

Group Type: EXPERIMENTAL

quinine sulfate

Intervention Type: DRUG

2 x 324 mg capsules (648 mg)

Interventions

quinine sulfate

2 x 324 mg capsules (648 mg)

Intervention Type: DRUG

quinine sulfate

2 x 324 mg capsules (648 mg)

Intervention Type: DRUG

Other Intervention Names

Qualaquin; Qualaquin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mutual Pharmaceutical Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaetano Morelli, MD

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Matthew Davis, MD

Role: STUDY_CHAIR

Mutual Pharmaceutical Company, Inc.

Locations

MDS Pharma Services

Saint Laurent, Montreal, Quebec, Canada

Countries

Canada

Related Links

http://www.fda.gov/opacom/7alerts.HTML

Recalls, Market Withdrawals and Safety Alerts

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Daily Med

Other Identifiers

MPC-001-07-1004

Identifier Type: -

Identifier Source: org_study_id