[Translation] Single-center, randomized, open-label, two-dose, single-dose, two-period, two-sequence, double-crossover bioequivalence study protocol for norfloxacin capsules in healthy subjects under fasting conditions
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(生产厂家:武汉同济现代医药科技股份有限公司)与参比制剂诺氟沙星片(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: Taking pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral preparation Norfloxacin Capsules (manufacturer: Wuhan Tongji Modern Pharmaceutical Technology Co., Ltd.) and the reference preparation Norfloxacin under fasting state Pharmacokinetic behavior in healthy subjects after tablets (licensee: Kyorin Pharmaceutical Co., Ltd., trade name: BACCIDAL®) to evaluate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the tested preparation norfloxacin capsules and the reference preparation norfloxacin tablets in healthy subjects.