[Translation] Cefprozil tablets (calculated as C18H19N3O5S, 250mg) produced by Guangdong Hengjian Pharmaceutical Co., Ltd. and Cefprozil tablets (calculated as C18H19N3O5S, 250mg) licensed by Lupin LTD in healthy subjects were single dosed, randomized, open, Bioequivalence study in two-period, double-crossover, fasting and fed states
主要研究目的:以 Lupin LTD 持证的头孢丙烯片(按 C18H19N3O5S 计,250mg)为参比制剂,以广东恒健制药有限公司生产的头孢丙烯片(按C18H19N3O5S计,250mg)为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂在空腹及餐后状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study: taking cefprozil tablets (calculated as C18H19N3O5S, 250mg) licensed by Lupine LTD as the reference preparation, and cefprozil tablets (calculated as C18H19N3O5S, 250mg) produced by Guangdong Hengjian Pharmaceutical Co., Ltd. as the test preparation, passed Single-center, randomized, open, single-dose, two-period, double-crossover clinical studies were conducted to evaluate the human bioequivalence of the two preparations in the fasting and postprandial states.
Secondary research purpose: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.