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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550926
First Posted: March 12, 2012
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Fecal fat excretion [ Time Frame: 9 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 17, 2011
First Posted: March 12, 2012
Last Update Posted: January 28, 2013
Last Verified: April 2012

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