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

November 17, 2011
January 24, 2013
February 2009
March 2009   (final data collection date for primary outcome measure)
Fecal fat excretion [ Time Frame: 9 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01550926 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms

The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Overweight
  • Drug: 120 mg orlistat
    2 X60 mg capsule
  • Drug: 60 mg orlistat
    60 mg orlistat
  • Drug: orlistat experimental dose
    experimental
  • Active Comparator: Arm 1
    60 mg orlistat
    Intervention: Drug: 60 mg orlistat
  • Active Comparator: Arm 2
    120 mg orlistat (2 X 60 mg capsules)
    Intervention: Drug: 120 mg orlistat
  • Experimental: Arm 3
    orlistat experimental formulation
    Intervention: Drug: orlistat experimental dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01550926
W3680604
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP