Bioequivalence Clinical Trial
Official title:
An Randomized, Three-treatment, Three-period, Three-sequence, Multiple Dose, Crossover, Comparative Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg In Normal, Healthy, Adult, Human Subjects Under Fed Conditions
The study will start with a run-in period with controlled diet and no drug for 5 consecutive days. This is to accustom the subjects to the standardized diet and also to determine baseline fecal fat excretion. After run-in period, subjects will be randomized to receive either test or reference orlistat formulations (60 mg or 120 mg) thrice daily under fed conditions for 10 consecutive days.
To assess the pharmacodynamic equivalence of orlistat, using fat excreted in feces, from sponsor's test product relative to that of reference product in normal, healthy, adult, human subjects under fed conditions. ;
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