Dose-ranging study of an orlistat tablet formulation

Dose-ranging study of an orlistat tablet formulation

Examine inhibition of dietary fat absorption with orlistat tablets (24, 36, 48, 72, and 144 mg) vs. 60-mg orlistat capsule. 83 overweight/obese subjects randomized to 1 of 6 open-label treatments. Pre- vs. post-treatment fecal fat analysis was conducted. Mean percent fecal fat (60-mg capsule, 16.8%;...

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Bibliographic Details
Published in:International journal of clinical pharmacology and therapeutics Vol. 56; no. 10; pp. 476 - 481
Main Authors: Schwartz, Susan M, Savastano, David M
Format: Journal Article
Language:English
Published: Germany Dustri - Verlag Dr. Karl Feistle GmbH & Co. KG 01-10-2018
Subjects:
Bioavailability
Body mass index
Diet
Drug dosages
FDA approval
Feces
Food
Obesity
Oils & fats
Standard deviation
Weight control
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Summary:Examine inhibition of dietary fat absorption with orlistat tablets (24, 36, 48, 72, and 144 mg) vs. 60-mg orlistat capsule. 83 overweight/obese subjects randomized to 1 of 6 open-label treatments. Pre- vs. post-treatment fecal fat analysis was conducted. Mean percent fecal fat (60-mg capsule, 16.8%; 48-mg tablet, 16.5%) was similar (ratio of geometric mean and 90% CI: 60-mg capsule/48-mg tablet, 1.05 (0.79, 1.39)). Fecal fat excretion was ~2.5 times greater with 144-mg vs. 24-mg tablets. No new safety concerns emerged. Dietary fat excretion increases with increasing orlistat tablet dose.
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Bibliography:ObjectType-Article-2
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ISSN:0946-1965
DOI:10.5414/CP203191