[Translation] Fasting: Mosapride citrate tablets produced by Ningbo Menohua Tiankang Pharmaceutical Co., Ltd. and Mosapride citrate tablets produced by Sumitomo Dainippon Pharma Co., Ltd. ®/Gasmotin®) in Chinese healthy subjects, a single-center, randomized, open-label, two-drug, fasting, single-dose, two-period, double-crossover design bioequivalence study
After meals: Mosapride citrate tablets produced by Ningbo Menohua Tiankang Pharmaceutical Co., Ltd. and Mosapride citrate tablets (trade name: Gas Qing®/Gasmotin®), a single-center, randomized, open-label, two-drug, postprandial, single-dose, four-period, repeated crossover design bioequivalence study in Chinese healthy subjects
以宁波美诺华天康药业有限公司生产的枸橼酸莫沙必利片(规格:5 mg)为受试制剂,持证商为Sumitomo Dainippon Pharma Co., Ltd.的枸橼酸莫沙必利片(商品名:加斯清®/Gasmotin ®,规格:5 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性,同时评价两制剂在健康受试者中的安全性。
[Translation] Mosapride citrate tablets (specification: 5 mg) produced by Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. was used as the test preparation, and the licensee was Mosapride citrate from Sumitomo Dainippon Pharma Co., Ltd. Li Pian (trade name: Gasmotin®/Gasmotin®, specification: 5 mg) was used as the reference preparation, and the pharmacokinetic parameters and relative bioavailability of the two preparations in a single administration under fasting and postprandial states were investigated. Evaluate whether the two preparations have bioequivalence, and evaluate the safety of the two preparations in healthy subjects.