simethicone and mosapride

Abbott Laboratories de México S.A. de C.V. developed a new fixed-dose combination of mosapride 5 mg, pancreatin 170 mg, and simethicone 125 mg as an alternative to the mosapride monotherapy to improve overall satisfaction and adequate relief of gastrointestinal disorders symptoms and to reduce multiple pill burden. As a part of the fixed-dose combination registration process in Mexico, a pharmacokinetic and relative bioavailability study was carried out to demonstrate nonexistence of pharmacokinetic interaction when mosapride is administered alone or in combination with pancreatin and simethicone using DOSIER® (mosapride) 5-mg tablets as a reference product. Tolerability of the fixed-dose combination tablet was assessed. In this open-label, randomized, oral single-dose, two-way crossover study, 65 healthy male and female subjects received either the fixed-dose combination tablet or the reference product during each study period. The two study periods were separated by a 7-day washout period. Mosapride concentrations in plasma samples were determined using a validated ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method. Blood samples were collected for up to 16 h post dose. The primary evaluation criteria were C

Topics: Area Under Curve; Benzamides; Biological Availability; Chromatography, Liquid; Cross-Over Studies; Female; Humans; Male; Mexico; Morpholines; Pancreatin; Simethicone; Tablets; Tandem Mass Spectrometry; Therapeutic Equivalency