富马酸伏诺拉生片在健康受试者中随机、开放、两制剂、单次给药、两周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] Bioequivalence study of vornolan fumarate tablets in healthy subjects under randomized, open-label, two-dose, single-dose, two-period, double-crossover fasting and fed states
主要目的:以湖南先施制药有限公司研制的富马酸伏诺拉生片为受试制剂,以Takeda Pharmaceutical Company Limited持证的富马酸伏诺拉生片(商品名:沃克)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。
次要目的:评价中国健康受试者单次空腹/餐后口服富马酸伏诺拉生片受试制剂和参比制剂后的安全性。
[Translation] Main purpose: Take fumarate raw fumarate tablets developed by Hunan Xianshi Pharmaceutical Co., Ltd. as the test preparation, and takeda fumarate raw fumarate tablets (trade name: Walker) licensed by Takeda Pharmaceutical Company Limited as reference Preparations, investigate the pharmacokinetic parameters and relative bioavailability of single administration of the two preparations in the fasting and postprandial state, and evaluate whether the two preparations have bioequivalence.
Secondary purpose: To evaluate the safety of Chinese healthy volunteers after single oral administration of Vonolasin Fumarate Tablets test preparation and reference preparation on an empty stomach/after meal.
罗沙司他胶囊在健康受试者中随机、开放、两制剂、单次给药、双周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] Bioequivalence study of roxadustat capsules in healthy subjects under randomized, open-label, two-dose, single-dose, double-period, double-crossover fasting and fed states
主要目的:以湖南先施制药有限公司研制的罗沙司他胶囊为受试制剂,以珐博进(中国)医药技术开发有限公司生产的罗沙司他胶囊(商品名:爱瑞卓®)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。
次要目的:评价中国健康受试者单次空腹/餐后口服罗沙司他胶囊受试制剂和参比制剂后的安全性。
[Translation] Main purpose: use roxadustat capsules developed by Hunan Xianshi Pharmaceutical Co., Ltd. as the test preparation, and roxadustat capsules (trade name: Arizhuo®) produced by Fibrojin (China) Pharmaceutical Technology Development Co., Ltd. As a reference preparation, the pharmacokinetic parameters and relative bioavailability of a single administration of the two preparations under fasting and postprandial states were investigated, and whether the two preparations had bioequivalence was evaluated.
Secondary objective: To evaluate the safety of Chinese healthy subjects after oral administration of the test preparation and the reference preparation of roxadustat capsules on an empty stomach/after meals.
硫辛酸片随机、开放、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 trial of bioequivalence of lipoic acid tablets randomized, open, crossover design in Chinese healthy subjects
以湖南先施制药有限公司的硫辛酸片为受试制剂;并以MEDA Pharma GmbH & Co. KG的硫辛酸片为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] The lipoic acid tablet of Hunan Xianshi Pharmaceutical Co., Ltd. was used as the test preparation; and the lipoic acid tablet of MEDA Pharma GmbH & Co. KG was used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.
100 Clinical Results associated with Hunan Xianshi Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hunan Xianshi Pharmaceutical Co., Ltd.
100 Deals associated with Hunan Xianshi Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hunan Xianshi Pharmaceutical Co., Ltd.