[Translation] Human bioequivalence study of oral acarbose tablets in Chinese healthy subjects under fasting, single, crossover, open and random states
主要目的:(1)预试验:探索阿卡波糖片在中国健康受试者体内的剂量-降糖效应关系,确定正式试验的给药剂量;初步考察空腹状态下单次口服受试制剂和参比制剂后的药效动力学参数,为正式试验的受试者例数提供进一步依据。(2)正式试验:以福建省宝诺医药研发有限公司提供的阿卡波糖片为受试制剂(T),拜耳医药保健有限公司生产的阿卡波糖片(商品名:拜唐苹®)为参比制剂(R),考察健康受试者在空腹状态下单次口服受试制剂和参比制剂的药效动力学参数,评价两制剂的生物等效性。
次要目的:评估受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purposes: (1) Preliminary test: To explore the dose-lowering blood sugar effect relationship of acarbose tablets in Chinese healthy subjects, to determine the dosage of the formal test; The pharmacodynamic parameters after the reference preparation provide further basis for the number of subjects in the formal test. (2) Formal test: Acarbose tablets provided by Fujian Baonuo Pharmaceutical Research and Development Co., Ltd. were used as the test preparation (T), and Acarbose tablets produced by Bayer Healthcare Co., Ltd. (trade name: Baitangping® ) is the reference preparation (R), investigate the pharmacodynamic parameters of the test preparation and the reference preparation in a single oral administration in a fasting state by healthy subjects, and evaluate the bioequivalence of the two preparations.
Secondary objective: To assess the safety of the test formulation and the reference formulation in healthy subjects.