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

Phase 1

Completed

• Conditions: Overweight
• Interventions: Drug: 60 mg orlistat; Drug: 120 mg orlistat; Drug: orlistat experimental dose

• Registration Number: NCT01550926
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Status Verified: 2012-04
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	60 mg orlistat	60 mg orlistat
Arm 2	120 mg orlistat	120 mg orlistat (2 X 60 mg capsules)
Arm 3	orlistat experimental dose	orlistat experimental formulation

Primary Outcome Measures

Name	Time	Method
Fecal fat excretion	9 days

Trial Locations

Locations (1)

MDS Pharma Services; 🇬🇧 Belfast, N. Ireland, United Kingdom