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
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

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 September 18, 2014