Last updated: 11/16/2018 21:00:18

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

GSK study ID
W2651062
See study documents
Clinicaltrials.gov ID
Not applicable
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 Pharmacodynamic Equivalence of Two Orlistat Dosage Forms
Trial description: This study will assess pharmacodynamic equivalence between a marketed orlistat formulation and a prototype formulation in healthy overweight to obese subjects.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

total excreted dietary fat in faeces in 24 hr

Timeframe: after 9 days of treatemnt

Secondary outcomes:
Not applicable
Interventions:
  • Drug: orlistat
    • Enrollment:
    144
    Primary completion date:
    2010-01-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Overweight
    Product
    orlistat
    Collaborators
    Not applicable
    Study date(s)
    September 2010 to December 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 Year
    Accepts healthy volunteers
    yes
    • Inclusion Criteria:
    • overweight to obese subjects (BMI 25-33)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • overweight to obese subjects (BMI 25-33)
    • otherwise healthy
    • non-smoking

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    2010-01-12
    Actual study completion date
    2010-01-12

    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website