Drug-Drug Interaction Study of Qualaquin and Midazolam
Completed
Mutual Pharmaceutical Company, Inc.
Phase 1
2007-03-01
This is an open label non-randomized single sequence, single group two way drug interaction
study in healthy adult volunteers to determine the extent to which quinine, an inducer of
cytochrome p450 CYP 3A4, affects the pharmacokinetics of midazolam, an accepted probe drug
for CYP 3A4. The study will also determine the extent to which midazolam affects the
pharmacokinetics of quinine.
Comparative Study of Quinine Sulfate in Healthy Patients and in Patients With Renal Impairment
Terminated
Mutual Pharmaceutical Company, Inc.
Phase 1
2007-11-01
The effects of mild or moderate renal impairment (creatinine clearance 30 to 50 ml/min or >50
to 80 ml/min, respectively) on the pharmacokinetic profile of quinine and its active
metabolite, 3'-hydroxyquinine, will be investigated. Safety and tolerability in healthy
subjects versus those with mild to moderate renal impairment will be compared, as well.
Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding
Completed
Mutual Pharmaceutical Company, Inc.
Phase 1
2007-07-01
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.
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