[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence crossover bioequivalence study of cefixime dispersible tablets in healthy subjects: fasting and fed
主要目的:以四川赛卓药业股份有限公司提供的头孢克肟分散片为受试制剂,按生物等效性试验的有关规定,与长生堂制药株式会社生产的头孢克肟细粒(Cefspan)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。次要目的:观察受试制剂头孢克肟分散片和参比制剂头孢克肟细粒在健康受试者中的安全性。
[Translation] Primary objective: To compare the absorption rate and extent of cefixime dispersible tablets provided by Sichuan Saizhuo Pharmaceutical Co., Ltd. with cefixime granules (Cefspan) produced by Changshengtang Pharmaceutical Co., Ltd. in healthy human subjects according to the relevant provisions of bioequivalence test, and to investigate the bioequivalence of the two preparations in human subjects. Secondary objective: To observe the safety of the test preparation cefixime dispersible tablets and the reference preparation cefixime granules in healthy subjects.