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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 17, 2011
Last updated: January 24, 2013
Last verified: April 2012
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
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: 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


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

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 identifier: NCT01550926

United Kingdom
MDS Pharma Services
Belfast, N. Ireland, United Kingdom, BT9 6AD
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01550926     History of Changes
Other Study ID Numbers: W3680604
Study First Received: November 17, 2011
Last Updated: January 24, 2013

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents processed this record on May 25, 2017