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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

Tracking Information
First Submitted Date  ICMJE November 17, 2011
First Posted Date  ICMJE March 12, 2012
Last Update Posted Date January 28, 2013
Study Start Date  ICMJE February 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
Fecal fat excretion [ Time Frame: 9 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
Official Title  ICMJE A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Overweight
Intervention  ICMJE
  • Drug: 120 mg orlistat
    2 X60 mg capsule
  • Drug: 60 mg orlistat
    60 mg orlistat
  • Drug: orlistat experimental dose
    experimental
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2012)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01550926
Other Study ID Numbers  ICMJE W3680604
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date April 2012

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