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Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg

NCT05076474 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-10-13

No results posted yet for this study

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.

Conditions

  • Bioequivalence

Interventions

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.

Sponsors & Collaborators

  • Shandong New Time Pharmaceutical Co., LTD

    lead INDUSTRY

Principal Investigators

  • Xin Li, Doctor · Changsha Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-03-01
Completion
2021-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05076474 on ClinicalTrials.gov