Last updated: 11/16/2018 21:00:18
A Study to Assess the Pharmacodynamic Equivalence of Two Orlistat Dosage Forms
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2010-01-12
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
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
2010-01-12
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
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