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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Overweight

Treatments: Drug: 60 mg orlistat; Drug: 120 mg orlistat; Drug: orlistat experimental dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01550926

W3680604

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

48 participants in 3 patient groups

Arm 1

Active Comparator group

Description:

60 mg orlistat

Treatment:

Drug: 60 mg orlistat

Arm 2

Active Comparator group

Description:

120 mg orlistat (2 X 60 mg capsules)

Treatment:

Drug: 120 mg orlistat

Arm 3

Experimental group

Description:

orlistat experimental formulation

Treatment:

Drug: orlistat experimental dose