[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, double-crossover bioequivalence study of norfloxacin capsules (0.1 g) in healthy subjects under fasting condition
主要目的:以白云山汤阴东泰药业有限责任公司生产的诺氟沙星胶囊(规格:0.1 g)为受试制剂,以杏林製薬株式会社生产的诺氟沙星片(商品名:BACCIDAL,规格:0.1 g)为参比制剂,进行空腹状态下人体生物等效性试验,评价受试制剂与参比制剂的生物等效性。
次要目的:观察空腹状态下,受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Norfloxacin capsules (specification: 0.1 g) produced by Baiyunshan Tangyin Dongtai Pharmaceutical Co., Ltd. were used as the test preparation, and norfloxacin tablets produced by Xinglin Pharmaceutical Co., Ltd. (trade name: BACCIDAL (specification: 0.1 g) is a reference preparation. Human bioequivalence tests are conducted under fasting conditions to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary purpose: To observe the safety of test preparation and reference preparation in healthy subjects under fasting state.