[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of moxifloxacin hydrochloride tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂盐酸莫西沙星片(规格:0.4g(按C21H24FN3O4计);生产企业:郑州韩都药业集团有限公司)和参比制剂盐酸莫西沙星片(商品名:拜复乐®(Avelox®);规格:0.4g(按C21H24FN3O4计);持证商:Bayer Vital GmbH)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂盐酸莫西沙星片和参比制剂盐酸莫西沙星片(拜复乐®(Avelox®))在中国健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation Moxifloxacin Hydrochloride Tablets (Specification: 0.4g (calculated as C21H24FN3O4); Manufacturer: Zhengzhou Handu Pharmaceutical Group Co., Ltd.) and the reference preparation Moxifloxacin Hydrochloride Tablets (Trade name: Avelox®; Specification: 0.4g (calculated as C21H24FN3O4); Licensee: Bayer Vital GmbH) in Chinese healthy subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in the fasting/fed state.
Secondary objective: To observe the safety of the test preparation Moxifloxacin Hydrochloride Tablets and the reference preparation Moxifloxacin Hydrochloride Tablets (Avelox®) in Chinese healthy subjects.