[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, self-crossover bioequivalence study of norfloxacin capsules in healthy participants under fasting condition
本试验旨在研究单剂量空腹口服国药集团汕头金石制药有限公司研制、生产的诺氟沙星胶囊(0.1g)的药代动力学特征,并以杏林製薬株式会社持证的诺氟沙星片(BACCIDAL®,0.1g)作为参比制剂,比较两制剂的药动学参数,以评价两制剂的人体生物等效性,并观察受试制剂和参比制剂在健康参与者中的安全性。
[Translation] This study aims to study the pharmacokinetic characteristics of a single fasting oral dose of norfloxacin capsules (0.1 g) developed and produced by Shantou Jinshi Pharmaceutical Co., Ltd. of Sinopharm Group, and to use norfloxacin tablets (BACCIDAL®, 0.1 g) certified by Kyorin Pharmaceutical Co., Ltd. as the reference preparation. The pharmacokinetic parameters of the two preparations are compared to evaluate the human bioequivalence of the two preparations and to observe the safety of the test preparation and the reference preparation in healthy participants.