[Translation] A study to evaluate the bioequivalence of the test product, moxifloxacin hydrochloride tablets, and the reference product, Avelox®, in healthy adult subjects in the fasting and fed states
主要研究目的:研究空腹和餐后状态下单次口服受试制剂盐酸莫西沙星片(北大医药股份有限公司生产)与参比制剂盐酸莫西沙星片(Avelox®,,Bayer HealthCare Manufacturing S.r.l.生产)在健康受试者体内的药代动力学,评价空腹和餐后状态下口服两种制剂的生物等效性。 次要研究目的:评估受试制剂盐酸莫西沙星片和参比制剂盐酸莫西沙星片(Avelox®)在健康受试者中的安全性。 次要研究目的:评估受试制剂盐酸莫西沙星片(规格:0.4 g)和参比制剂盐酸莫西沙星片(Avelox®,规格:0.4 g)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation Moxifloxacin Hydrochloride Tablets (produced by Peking University Pharmaceutical Co., Ltd.) and the reference preparation Moxifloxacin Hydrochloride Tablets (Avelox®, produced by Bayer HealthCare Manufacturing S.r.l.) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the oral bioequivalence of the two preparations in the fasting and fed state. The secondary purpose of the study is to evaluate the safety of the test preparation Moxifloxacin Hydrochloride Tablets and the reference preparation Moxifloxacin Hydrochloride Tablets (Avelox®) in healthy subjects. The secondary purpose of the study is to evaluate the safety of the test preparation Moxifloxacin Hydrochloride Tablets (specification: 0.4 g) and the reference preparation Moxifloxacin Hydrochloride Tablets (Avelox®, specification: 0.4 g) in healthy subjects.