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

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.
 
ClinicalTrials.gov Identifier: NCT01550926
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overweight Drug: 120 mg orlistat Drug: 60 mg orlistat Drug: orlistat experimental dose Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
Study Start Date : February 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Arms and Interventions
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Arm Intervention/treatment
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


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

Eligibility Criteria
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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
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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
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United Kingdom
MDS Pharma Services
Belfast, N. Ireland, United Kingdom, BT9 6AD
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01550926    
Other Study ID Numbers: W3680604
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: April 2012
Keywords provided by GlaxoSmithKline:
orlistat
overweight
bioequivalence
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms
Orlistat
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents