Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg

Summary

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.

Timeline

Start

2020-10-01

Primary completion

2021-03-01

Completion

2021-03-31

Drugs

Indications

No indication recorded.