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
  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:


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
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
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

No publications provided

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
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014