[Translation] A single-center, randomized, open-label, two-dose, fasting, single-dose, two-period, double-crossover bioequivalence study was conducted in healthy Chinese subjects. The study involved a single-center, randomized, open-label, two-dose, fasting, single-dose, two-period, double-crossover design of cimetidine tablets developed by Hebei Xinshi Pharmaceutical Co., Ltd. and cimetidine tablets (trade name: Tagamet HB®) from a licensed manufacturer MEDTECH PRODUCTS INC.
以河北新石制药有限公司研制的西咪替丁片(规格:0.2 g)为受试制剂,持证商为MEDTECH PRODUCTS INC的西咪替丁片(商品名:Tagamet HB®,规格:0.2 g)为参比制剂,考察两制剂在空腹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人体中的安全性和耐受性。
[Translation] Cimetidine tablets (specification: 0.2 g) developed by Hebei Xinshi Pharmaceutical Co., Ltd. were used as the test preparation, and cimetidine tablets (trade name: Tagamet HB®, specification: 0.2 g) from MEDTECH PRODUCTS INC were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration under fasting conditions were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.