[Translation] Study plan for a single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting bioequivalence trial of norfloxacin capsules in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,比较在空腹状态下口服受试制剂诺氟沙星胶囊(规格:0.1g,持证商:广东恒健制药有限公司)与参比制剂诺氟沙星片(规格:0.1g,持证商:杏林制药株式会社,商品名:BACCIDAL®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂诺氟沙星胶囊和参比制剂诺氟沙星片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the pharmacokinetic behavior of the test preparation norfloxacin capsule (specification: 0.1g, license holder: Guangdong Hengjian Pharmaceutical Co., Ltd.) and the reference preparation norfloxacin tablet (specification: 0.1g, license holder: Xinglin Pharmaceutical Co., Ltd., trade name: BACCIDAL®) in healthy subjects after oral administration in the fasting state, and evaluate the bioequivalence of the two preparations.
Secondary purpose: Observe the safety of the test preparation norfloxacin capsule and the reference preparation norfloxacin tablet in healthy subjects.