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

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

Completed

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MDS Pharma Services

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

120 mg orlistat

Drug

2 X60 mg capsule

60 mg orlistat

Drug

60 mg orlistat

orlistat experimental dose

Drug

experimental

Primary outcomes

Fecal fat excretion

Time frame: 9 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Mar 12, 2012
Registry last updated: Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed