/ CompletedNot Applicable 洛索洛芬钠细粒剂在健康受试者中随机、开放、两制剂、单次给药、双交叉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, double-crossover bioequivalence study of loxoprofen sodium fine granules in healthy subjects under fasting and fed conditions
研究空腹及餐后状态下单次口服受试制剂洛索洛芬钠细粒剂(规格:60mg,浙江赛默制药有限公司生产)与参比制剂洛索洛芬钠细粒剂(规格:10%(1g含无水物100mg),持证商:第一三共株式会社)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。
[Translation] The pharmacokinetics of the test preparation, loxoprofen sodium fine granules (specification: 60 mg, produced by Zhejiang Thermo Pharmaceutical Co., Ltd.) and the reference preparation, loxoprofen sodium fine granules (specification: 10% (1 g contains 100 mg of anhydrous substance), licensee: Daiichi Sankyo Co., Ltd.) were studied in healthy adult subjects after a single oral administration in the fasting and fed state, and the bioequivalence of the two preparations after oral administration in the fasting and fed state was evaluated.
/ CompletedNot Applicable 罗沙司他胶囊在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期、交叉对照空腹及餐后状态下的生物等效性研究
[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, cross-over controlled bioequivalence study of roxadustat capsules in healthy subjects under fasting and fed conditions
以湖南埃威格林医药科技有限公司提供的罗沙司他胶囊为受试制剂;并以珐博进(中国)医药技术开发有限公司的罗沙司他胶囊为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] Rosuvastatin capsules provided by Hunan Evergreen Pharmaceutical Technology Co., Ltd. were used as the test preparation, and rosuvastatin capsules produced by FibroGen (China) Pharmaceutical Technology Development Co., Ltd. were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.
/ CompletedNot Applicable 环丝氨酸胶囊随机、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 randomized, open-label, two-dose, crossover design formal bioequivalence trial of cycloserine capsules in Chinese healthy subjects
主要目的:以湖南埃威格林医药科技有限公司持证的环丝氨酸胶囊为受试制剂;并以Meiji Seikaファルマ株式会社的环丝氨酸胶囊为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] Main purpose: To evaluate the relative bioavailability and bioequivalence of cycloserine capsules produced by Hunan Evergreen Pharmaceutical Technology Co., Ltd. as the test preparation and cycloserine capsules produced by Meiji Seika Formula Co., Ltd. as the reference preparation.
100 Clinical Results associated with Hunan Evergreen Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Hunan Evergreen Pharmaceutical Technology Co., Ltd.
100 Deals associated with Hunan Evergreen Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Hunan Evergreen Pharmaceutical Technology Co., Ltd.