Last updated: 11/04/2018 13:42:42

A pharmacokinetic study of two oral formulations of orlistat

GSK study ID
W2650782
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 pharmacokinetic study of two oral formulations of orlistat
Trial description: The aim of this study is to evaluate the systemic absorption of an orlistat prototype formulation
and the marketed orlistat formulation to determine the blood levels of the two
major metabolites for both products.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Plasma levels of orlistat

Timeframe: up to 9 hours post dosing

Secondary outcomes:

Plasma levels of orlistat metabolites

Timeframe: up to 9 hours post dosing

Interventions:
  • Drug: Marketed Orlistat
  • Drug: Prototype Orlistat
    • Enrollment:
    22
    Primary completion date:
    2010-14-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Overweight
    Product
    orlistat
    Collaborators
    Not applicable
    Study date(s)
    January 2010 to February 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 Year
    Accepts healthy volunteers
    none
    • Inclusion Criteria:
    • Body Mass Index within the range of 25-33 kg/m2 inclusive, i.e. overweight
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Body Mass Index within the range of 25-33 kg/m2 inclusive, i.e. overweight

    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
    2010-14-02
    Actual study completion date
    2010-14-02

    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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