A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
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| ClinicalTrials.gov Identifier: NCT01550926 |
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Recruitment Status :
Completed
First Posted : March 12, 2012
Last Update Posted : January 28, 2013
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
- Study Details
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Brief Summary:
The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overweight | Drug: 120 mg orlistat Drug: 60 mg orlistat Drug: orlistat experimental dose | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 48 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Official Title: | A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | March 2009 |
| Actual Study Completion Date : | March 2009 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Orlistat
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm 1
60 mg orlistat
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Drug: 60 mg orlistat
60 mg orlistat
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Active Comparator: Arm 2
120 mg orlistat (2 X 60 mg capsules)
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Drug: 120 mg orlistat
2 X60 mg capsule
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Experimental: Arm 3
orlistat experimental formulation
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Drug: orlistat experimental dose
experimental
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Primary Outcome Measures :
- Fecal fat excretion [ Time Frame: 9 days ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550926
Locations
| United Kingdom | |
| MDS Pharma Services | |
| Belfast, N. Ireland, United Kingdom, BT9 6AD | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01550926 History of Changes |
| Other Study ID Numbers: |
W3680604 |
| First Posted: | March 12, 2012 Key Record Dates |
| Last Update Posted: | January 28, 2013 |
| Last Verified: | April 2012 |
Keywords provided by GlaxoSmithKline:
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orlistat overweight bioequivalence |
Additional relevant MeSH terms:
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Overweight Body Weight Signs and Symptoms Orlistat |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Obesity Agents |