[Translation] A randomized, open-label, two-preparation, single-dose, fasting and postprandial bioequivalence study of doxycycline hydrochloride tablets in healthy subjects
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,杭州绿哲医药科技有限公司持证)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口服两种制剂的生物等效性。
[Translation] Main purpose: To study the single oral administration of the test preparation doxycycline hydrochloride tablets (specification: 0.1g, certified by Hangzhou Lvzhe Pharmaceutical Technology Co., Ltd.) and the reference preparation doxycycline hydrochloride tablets (commercial product) under fasting and postprandial conditions. Name: Vibramycin®, strength: 100mg, licensee: Pfizer Japan Inc.) in healthy adult subjects, to evaluate the bioequivalence of the two oral preparations in fasting and postprandial states.