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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2009-31-03
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
Completed
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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