A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01550926

Enrollment

Registered

2012-03-12

Start date

2009-02-28

Completion date

2009-03-31

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

orlistat, overweight, bioequivalence

Brief summary

The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.

Interventions

DRUG120 mg orlistat

2 X60 mg capsule

DRUG60 mg orlistat

60 mg orlistat

DRUGorlistat experimental dose

experimental

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* age: 18-60 years * Body Mass Index: 25-33

Exclusion criteria

* gastrointestinal disease * organ transplant * HIV, hepatitis B or C * food allergies * alcohol or other substance abuse * smoking

Design outcomes

Primary

Measure	Time frame
Fecal fat excretion	9 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026