[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover controlled bioequivalence study of doxycycline hydrochloride tablets in healthy subjects under fasting and fed conditions
主要目的:研究空腹及餐后状态下单次口服受试制剂盐酸多西环素片(规格:0.1g,浙江益汉制药有限公司持证)与参比制剂盐酸多西环素片(商品名:Vibramycin®,规格:100mg,持证商:Pfizer Japan Inc.)在健康成年受试者体内的药代动力学,评价空腹及餐后状态下口服两种制剂的生物等效性。
次要目的:研究受试制剂盐酸多西环素片和参比制剂盐酸多西环素片在健康成年受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of the test preparation doxycycline hydrochloride tablets (specification: 0.1g, licensed by Zhejiang Yihan Pharmaceutical Co., Ltd.) and the reference preparation doxycycline hydrochloride tablets (trade name: Vibramycin®, specification: 100mg, licensed by Pfizer Japan Inc.) in healthy adult subjects after a single oral administration in fasting and postprandial states, and to evaluate the bioequivalence of the two preparations after oral administration in fasting and postprandial states.
Secondary objective: To study the safety of the test preparation doxycycline hydrochloride tablets and the reference preparation doxycycline hydrochloride tablets in healthy adult subjects.