Status:
COMPLETED
Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 pudd...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00806078
Start Date
July 1 2007
End Date
August 1 2007
Last Update
August 31 2012
Active Locations (1)
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1
MDS Pharma Services
Saint Laurent, Montreal, Quebec, Canada, H4R 2N6