塞来昔布胶囊在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of celecoxib capsules in fasting and fed subjects
本研究考察空腹及餐后条件下单次口服由福州闽海药业有限公司提供的塞来昔布胶囊(受试制剂)与由G.D.Searle LLC持证的塞来昔布胶囊(参比制剂)在健康受试者中的药动学特征,评价两制剂的生物等效性,为该受试制剂注册申请提供依据。同时考察安全性。
[Translation] This study investigated the pharmacokinetic characteristics of celecoxib capsules (test preparation) provided by Fuzhou Minhai Pharmaceutical Co., Ltd. and celecoxib capsules (reference preparation) certified by G.D.Searle LLC in healthy subjects after a single oral administration under fasting and postprandial conditions, evaluated the bioequivalence of the two preparations, and provided a basis for the registration application of the test preparation. Safety was also investigated.
盐酸罗沙替丁醋酸酯缓释胶囊在健康受试者中空腹/餐后生物等效性试验
[Translation] Fasting/fed bioequivalence study of roxatidine acetate hydrochloride extended-release capsules in healthy volunteers
以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂与参比制剂后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性,同时评价两个制剂的安全性。
[Translation] Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behaviors of the test preparation and the reference preparation in healthy subjects after oral administration in the fasting/postprandial state were compared to evaluate the bioequivalence of the two preparations and the safety of the two preparations.
100 Clinical Results associated with Fuzhou Minhai Pharmaceutical Co. Ltd.
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