[Translation] Randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of norfloxacin capsules (0.1g) in Chinese healthy subjects under fasting administration conditions
主要研究目的:按有关生物等效性试验的规定,选择杏林制药株式会社为持证商的诺氟沙星片(商品名:BACCIDAL®,规格:100mg/片)为参比制剂,对哈药集团制药六厂生产、哈药集团制药总厂提供的受试制剂诺氟沙星胶囊(规格:0.1g/粒)进行空腹给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评估两种制剂在空腹给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂诺氟沙星胶囊(规格:0.1g/粒)和参比制剂诺氟沙星片(商品名:BACCIDAL®,规格:100mg/片)的安全性。
[Translation] Main research purpose: According to the regulations on bioequivalence testing, Norfloxacin Tablets (trade name: BACCIDAL®, specification: 100mg/tablet) of Xinglin Pharmaceutical Co., Ltd. as a licensee was selected as the reference preparation. The test preparation norfloxacin capsules (specification: 0.1g/capsule) produced by the Sixth Pharmaceutical Factory of the Group and provided by the Harbin Pharmaceutical Group General Pharmaceutical Factory were subjected to fasting administration human bioequivalence tests to compare the absorption speed of the drugs in the test preparations. And whether the difference in absorption degree and reference preparation is within the acceptable range, evaluate the bioequivalence of the two preparations under fasting administration conditions.
Secondary research purpose: To observe the oral administration of test preparation norfloxacin capsules (specification: 0.1g/tablet) and reference preparation norfloxacin tablets (trade name: BACCIDAL®, specification: 100mg/tablet) to healthy volunteer subjects. security.