Overview

Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg

Status:
Completed
Trial end date:
2021-03-31
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Shandong New Time Pharmaceutical Co., LTD
Treatments:
Orlistat