Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding
Information source: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: quinine sulfate (Drug); quinine sulfate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mutual Pharmaceutical Company, Inc. Official(s) and/or principal investigator(s): Gaetano Morelli, MD, Principal Investigator, Affiliation: MDS Pharma Services Matthew Davis, MD, Study Chair, Affiliation: Mutual Pharmaceutical Company, Inc.
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Maximum Observed Plasma Concentration (Cmax)Area Under the Concentration Time Curve From Zero to t. (AUC 0-t) The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf)
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
MDS Pharma Services, Saint Laurent, Montreal, Quebec H4R 2N6, Canada
Additional Information
Recalls, Market Withdrawals and Safety Alerts Daily Med
Starting date: July 2007
Last updated: August 22, 2012
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