[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of sitafloxacin granules (50 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择第一三共株式会社为持证商的西他沙星颗粒(规格:10%(30g))为参比制剂,对济川药业集团有限公司生产的受试制剂西他沙星颗粒(规格:50mg)进行空腹和餐后给药生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,比较两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂西他沙星颗粒(规格:50mg)和参比制剂西他沙星颗粒(规格:10%(30g))的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, the sitafloxacin granules (specification: 10% (30g)) of Daiichi Sankyo Co., Ltd. as the licensee was selected as the reference preparation, and the test preparation sitafloxacin granules (specification: 50mg) produced by Jichuan Pharmaceutical Group Co., Ltd. were subjected to fasting and postprandial bioequivalence test to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the safety of oral administration of the test preparation sitafloxacin granules (specification: 50mg) and the reference preparation sitafloxacin granules (specification: 10% (30g)) by healthy volunteers.