Dose-ranging study of an orlistat tablet formulation.

Objective: Examine inhibition of dietary fat absorption with orlistat tablets (24, 36, 48, 72, and 144 mg) vs. 60-mg orlistat capsule.

Materials And Methods: 83 overweight/obese subjects randomized to 1 of 6 open-label treatments. Pre- vs. post-treatment fecal fat analysis was conducted.

Results: 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.

Conclusion: Dietary fat excretion increases with increasing orlistat tablet dose.
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