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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2010-14-02
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)

No location data available.

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