NCT05076474

Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Orlistat 60mg Cap	Subjects completed a 5-day run-in period (baseline) and then were randomized to receive the first of 3 treatments; each treatment period lasted 10 days followed by a 4-day washout period between treatments.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-03-01
• Completion: 2021-03-31
• First posted: 2021-10-13
• Last updated: 2021-10-13

Locations

1 site across 1 country: China