Last updated: 11/15/2018 22:20:14
A Dose-Ranging Study of a Tablet Formulation of Orlistatn/a
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Dose-Ranging Study of a Tablet Formulation of Orlistat
Trial description: The aim of this study is to compare the activity of several orlistat tablet doses to 60mg orlistat capsules.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Fecal Fat Excretion
Timeframe: Up to 9 days post baseline
Secondary outcomes:
Not applicable
Interventions:
Drug: Experimental dose 2
Drug: Experimental dose 4
Drug: Experimental dose 1
Drug: Experimental dose 3
Drug: Marketed formulation
Drug: Experimental dose 5
Enrollment:
84
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Overweight
Product
orlistat
Collaborators
Not applicable
Study date(s)
June 2009 to September 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 60 Year
Accepts healthy volunteers
none
- Healthy, male or female, aged 18-60, Body Mass Index (BMI) of 25-33
- Pregnant/breastfeeding, current history of gastro-intestinal (GI) disease or taking medications that affect normal GI function, clinically significant and relevant abnormalities of medical history or physical examination, orlistat use within one month prior to screening, current smoker, participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy, male or female, aged 18-60, Body Mass Index (BMI) of 25-33
Exclusion criteria:
- Pregnant/breastfeeding, current history of gastro-intestinal (GI) disease or taking medications that affect normal GI function, clinically significant and relevant abnormalities of medical history or physical examination, orlistat use within one month prior to screening, current smoker, participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
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
Not applicable
Actual study completion date
2009-09-09
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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