盐酸多西环素片在健康受试者中随机、开放、两制剂、单次给药、空腹和餐后状态下的生物等效性研究
[Translation] A randomized, open-label, two-dose, single-dose, fasting and fed 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 objective: To study the pharmacokinetics of the test preparation doxycycline hydrochloride tablets (specification: 0.1g, licensed by Hangzhou Lvzhe Pharmaceutical Technology 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 the fasting and fed state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting and fed state.
己酮可可碱缓释片随机、开放、两制剂、交叉设计在中国健康受试者中的生物等效性正式试验
[Translation] A formal bioequivalence study of pentoxifylline extended-release tablets in Chinese healthy subjects using a randomized, open-label, two-dose, crossover design
主要目的:研究空腹/餐后状态下单次口服受试制剂己酮可可碱缓释片(规格:0.4g,浙江赛默制药有限公司生产)与参比制剂己酮可可碱缓释片(Trental®,规格:400mg;Sanofi S.r.l公司生产)在健康成年受试者体内的药代动力学,评价空腹/餐后状态口服两种制剂的生物等效性。
[Translation] Main objective: To study the pharmacokinetics of the test preparation pentoxifylline sustained-release tablets (specification: 0.4g, produced by Zhejiang Thermo Pharmaceutical Co., Ltd.) and the reference preparation pentoxifylline sustained-release tablets (Trental®, specification: 400mg; produced by Sanofi S.r.l.) in healthy adult 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.
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