[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of cefaclor dry suspension (0.125 g) produced by Haikou Pharmaceutical Factory Co., Ltd. and cefaclor dry suspension (trade name: Xikeluo®, 0.125 g) certified by Suzhou Xikeluo Pharmaceutical Co., Ltd. in healthy subjects under fasting and fed conditions
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、双交叉临床研究进行人体生物等效性研究,为正式试验的研究方案设计提供数据支持。
[Translation] The main research purpose: Using the certified cefaclor dry suspension of Suzhou Xikro Pharmaceutical Co., Ltd. as the reference preparation and the cefaclor dry suspension produced by Haikou Pharmaceutical Factory Co., Ltd. as the test preparation, a human bioequivalence study was conducted through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study to provide data support for the design of the research plan for the formal trial.