[Translation] A single-center, single-dose, randomized, open-label, two-dose, two-period, crossover, postprandial bioequivalence study of cefixime capsules
主要研究目的:以海南日中天制药有限公司生产提供的头孢克肟胶囊(100mg/粒)为试验制剂,按有关生物等效性试验的规定,以长生堂制药株式会社生产的头孢克肟胶囊(100mg/粒)(商品名:Cefspan®)为参比制剂进行的餐后生物等效性试验。
次要研究目的:观察试验制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the study was to use the cefixime capsules (100 mg/capsule) produced by Hainan Rizhongtian Pharmaceutical Co., Ltd. as the test preparation, and the cefixime capsules (100 mg/capsule) (trade name: Cefspan®) produced by Changshengtang Pharmaceutical Co., Ltd. as the reference preparation for postprandial bioequivalence test according to the relevant provisions of bioequivalence test.
Secondary purpose of the study was to observe the safety of the test preparation and the reference preparation in healthy subjects.