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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01550926

First received: November 17, 2011

Last updated: January 24, 2013

Last verified: April 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
Overweight	Drug: 120 mg orlistat Drug: 60 mg orlistat Drug: orlistat experimental dose	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms

Resource links provided by NLM:

Drug Information available for: Orlistat

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Fecal fat excretion [ Time Frame: 9 days ] [ Designated as safety issue: No ]


Enrollment:	48
Study Start Date:	February 2009
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1 60 mg orlistat	Drug: 60 mg orlistat 60 mg orlistat
Active Comparator: Arm 2 120 mg orlistat (2 X 60 mg capsules)	Drug: 120 mg orlistat 2 X60 mg capsule
Experimental: Arm 3 orlistat experimental formulation	Drug: orlistat experimental dose experimental

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550926

Locations


United Kingdom
MDS Pharma Services
Belfast, N. Ireland, United Kingdom, BT9 6AD

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01550926 History of Changes
Other Study ID Numbers:	W3680604
Study First Received:	November 17, 2011
Last Updated:	January 24, 2013
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


orlistat overweight bioequivalence

Additional relevant MeSH terms:


Overweight Body Weight Signs and Symptoms Orlistat	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Obesity Agents

ClinicalTrials.gov processed this record on September 28, 2016

To Top