[Translation] A single-center, randomized, open-label, two-dose, two-period, two-sequence, single-dose, double-crossover bioequivalence study of norfloxacin tablets in Chinese healthy subjects under fasting condition
主要目的:以诺氟沙星片的体内药代动力学参数为生物等效性的评价指标,在中国健康受试者空腹状态下评估受试制剂(规格:0.1g;生产厂家:万邦德制药集团有限公司)和参比制剂(英文名:Norfloxacin Tablets;英文商品名:BACCIDAL;规格:0.1g;持证商:KYORIN Pharmaceutical Co.,Ltd.(日本杏林制药株式会社))的生物等效性。 次要目的:观察空腹口服受试制剂和参比制剂的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test preparation (specification: 0.1 g; manufacturer: Wanbangde Pharmaceutical Group Co., Ltd.) and the reference preparation (English name: Norfloxacin Tablets; English trade name: BACCIDAL; specification: 0.1 g; licensee: KYORIN Pharmaceutical Co., Ltd.) in Chinese healthy subjects under fasting state, using the in vivo pharmacokinetic parameters of norfloxacin tablets as the evaluation index of bioequivalence. Secondary objective: To observe the safety of the test preparation and the reference preparation when taken orally on an empty stomach.