[Translation] A single-center, randomized, open-label, two-dose, fasting and fed, single-dose, two-period, double-crossover bioequivalence study of rebamipide tablets developed by Hainan Kejin Biopharmaceutical Co., Ltd. and rebamipide tablets (trade name: Mucosta®) developed by Otsuka Pharmaceutical Co., Ltd. in healthy Chinese subjects
以海南科进生物制药有限公司的瑞巴派特片(0.1 g)为受试制剂,Otsuka pharmaceutical Co.Ltd上市的Mucosta®(规格0.1 g)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] Rebamipide tablets (0.1 g) produced by Hainan Kejin Biopharmaceutical Co., Ltd. was used as the test preparation, and Mucosta® (specification 0.1 g) marketed by Otsuka Pharmaceutical Co., Ltd. was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent, and the safety of the two preparations in healthy subjects was evaluated.