[Translation] Cefaclor dry suspension (0.125 g) produced by Haikou Pharmaceutical Factory Co., Ltd. and cefaclor dry suspension (trade name: Cekerao®, 0.125 g) licensed by Suzhou Sikero Pharmaceutical Co., Ltd. Single-dose, randomized, open-label, two-period, double-crossover, fasted and fed bioequivalence studies in healthy subjects
主要研究目的:以苏州西克罗制药有限公司持证的头孢克洛干混悬剂为参比制剂,以海口市制药厂有限公司生产的头孢克洛干混悬剂为受试制剂,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 the cefaclor dry suspension licensed by Suzhou Xikeluo Pharmaceutical Co., Ltd. as the reference preparation, and the cefaclor dry suspension produced by Haikou Pharmaceutical Factory Co., Ltd. as the test preparation, through a single Central, randomized, open, single-administration, two-period, double-crossover clinical study to evaluate the human bioequivalence of the two preparations in the fasting and fed states.
Secondary research purpose: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.