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] Human bioequivalence test of celecoxib capsules under fasting and postprandial conditions
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 single oral administration of celecoxib capsules (test preparation) provided by Fuzhou Minhai Pharmaceutical Co., Ltd. and celecoxib capsules (reference preparation) licensed by G.D.Searle LLC under fasting and postprandial conditions. The pharmacokinetic characteristics in healthy subjects and the evaluation of the bioequivalence of the two preparations provide the basis for the registration application of the test preparation. Also check for safety.
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/postprandial bioequivalence study of roxatidine hydrochloride acetate sustained-release capsules in healthy subjects
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] Taking the pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation and the reference preparation after oral administration in the fasting/postprandial state in healthy subjects were compared respectively, and the biological properties of the two preparations were evaluated. efficacy and the safety of both formulations.
100 Clinical Results associated with Fuzhou Minhai Pharmaceutical Co. Ltd.
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100 Translational Medicine associated with Fuzhou Minhai Pharmaceutical Co. Ltd.