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比拉斯汀片在健康受试者中空腹状态下随机、开放、两周期、双交叉生物等效性临床试验
[Translation] A randomized, open-label, two-cycle, double-crossover bioequivalence clinical trial of bilastine tablets in healthy subjects in the fasting state
主要目的:研究空腹状态下,单次口服比拉斯汀片受试制剂(规格:20mg,扬子江药业集团北京海燕药业有限公司)与参比制剂(商品名:Bilaxten®,规格:20mg,FAES Farma S.A.)在健康受试者中的药代动力学行为,评价两种制剂的生物等效性。
次要目的: 观察受试制剂和参比制剂( 商品名:Bilaxten®)在健康受试者中的安全性。
[Translation] Main purpose: To study the test preparation (specification: 20mg, Yangzijiang Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.) and the reference preparation (trade name: Bilaxten®, specification: 20mg, under fasting state) FAES Farma S.A.) pharmacokinetic behavior in healthy subjects to evaluate the bioequivalence of two formulations.
Secondary objective: To observe the safety of the test product and the reference product (trade name: Bilaxten®) in healthy subjects.
磷酸奥司他韦颗粒在中国成年健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两周期、双交叉的生物等效性研究
[Translation] A randomized, open-label, fasting and postprandial single-dose, two-agent, two-cycle, double-crossover bioequivalence study of oseltamivir phosphate granules in Chinese adult healthy subjects
主要目的是以扬子江药业集团北京海燕药业有限公司生产提供的磷酸奥司他韦颗粒为受试制剂,按生物等效性试验的有关规定,与中外制药株式会社生产的磷酸奥司他韦干糖浆(商品名:Tamiflu,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。次要目的是观察受试制剂磷酸奥司他韦颗粒和参比制剂磷酸奥司他韦干糖浆(Tamiflu)在健康受试者中的安全性。
[Translation] The main purpose is to use the oseltamivir phosphate granules produced by Yangzijiang Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd. as the test preparation. Dry syrup (trade name: Tamiflu, reference preparation) was compared with the absorption rate and degree of absorption in healthy humans, and the human bioequivalence of the two preparations was investigated. The secondary objective was to observe the safety of the test preparation oseltamivir phosphate granules and the reference preparation oseltamivir phosphate dry syrup (Tamiflu) in healthy subjects.
磷酸奥司他韦颗粒在健康受试者中随机、开放、两周期、双交叉空腹和餐后状态下生物等效性临床研究
[Translation] A randomized, open-label, two-cycle, double-crossover bioequivalence clinical study of oseltamivir phosphate granules in healthy subjects in fasting and postprandial states
主要目的是研究空腹或餐后状态下,单次口服受试制剂磷酸奥司他韦颗粒(规格:25mg,扬子江药业集团北京海燕药业有限公司)与参比制剂磷酸奥司他韦干糖浆剂(Tamiflu®,规格:3%(30g),中外制药株式会社)在中国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。次要目的是观察受试制剂和参比制剂(商品名:Tamiflu®)在中国健康受试者中的安全性。
[Translation] The main purpose is to study the single oral administration of the test preparation oseltamivir phosphate granules (specification: 25 mg, Yangzijiang Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.) and the reference preparation oseltamivir phosphate dry syrup in the fasting or postprandial state. The pharmacokinetic behavior of Tamiflu® (Tamiflu®, strength: 3% (30g), Chugai Pharmaceutical Co., Ltd.) in healthy Chinese subjects, and the bioequivalence of the two preparations was evaluated. The secondary objective was to observe the safety of the test preparation and reference preparation (trade name: Tamiflu®) in healthy Chinese subjects.
100 Clinical Results associated with Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.
100 Deals associated with Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.