Last updated: 11/04/2018 13:43:22

A study to assess the pharmacologic equivalence of two orlistat dosage forms

GSK study ID
W3680604
See study documents
Clinicaltrials.gov ID
NCT01550926
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A study to assess the pharmacologic equivalence of two orlistat dosage forms
Trial description: The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Fecal fat excretion

Timeframe: 9 days

Secondary outcomes:
Not applicable
Interventions:
  • Drug: 120 mg orlistat
  • Drug: 60 mg orlistat
  • Drug: orlistat experimental dose
    • Enrollment:
    48
    Primary completion date:
    2009-31-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Overweight
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    February 2009 to March 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    Yes
    • age: 18-60 years
    • Body Mass Index: 25-33
    • gastrointestinal disease
    • organ transplant
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    MDS Pharma Services
    Belfast, N. Ireland, United Kingdom, BT9 6AD
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2009-31-03
    Actual study completion date
    2009-31-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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    Access to clinical trial data by researchers
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