[Translation] Study on Bioequivalence of Omeprazole Enteric-coated Capsules in Fasting Human
以一力制药(罗定)有限公司提供的奥美拉唑肠溶胶囊为受试制剂,按生物等效性研究的有关规定,与AstraZeneca AB公司生产的奥美拉唑肠溶胶囊(商品名:Losec ®,参比制剂)对比在健康空腹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:观察受试制剂奥美拉唑肠溶胶囊和参比制剂奥美拉唑肠溶胶囊(Losec ®)在健康受试者中的安全性。
[Translation] Taking Omeprazole enteric-coated capsules provided by Yili Pharmaceutical (Luoding) Co., Ltd. : Losec ®, reference preparation) to compare the absorption rate and degree of absorption in healthy fasting human body, and investigate the human bioequivalence of the two preparations. Secondary purpose: To observe the safety of the test preparation omeprazole enteric-coated capsules and the reference preparation omeprazole enteric-coated capsules (Losec ® ) in healthy subjects.
非布司他片在中国健康受试者餐后状态下单中心、随机、开放、双周期、双交叉设计的生物等效性试验
[Translation] Bioequivalence trial of febuxostat tablets in Chinese healthy subjects in a single-center, randomized, open-label, two-period, two-crossover design
1.主要目的:评价广东一力罗定制药有限公司生产的非布司他片(规格:40mg)与原研药非布司他片(规格:40mg,商品名:Uloric®,Takeda Pharmaceuticals America, Inc.生产)在健康成年受试者餐后状态下单次口服给药的人体生物等效性。 2.次要目的:评价非布司他片在健康成年受试者中的安全性。
[Translation] 1. Main purpose: to evaluate the febuxostat tablets (specification: 40mg) produced by Guangdong Yililuo Custom Pharmaceutical Co., Ltd. and the original research drug febuxostat tablets (specification: 40mg, trade name: Uloric®, Takeda Pharmaceuticals America, Inc. . production) human bioequivalence of a single oral dose in healthy adult subjects in the fed state. 2. Secondary objective: To evaluate the safety of febuxostat tablets in healthy adult subjects.
非布司他片在中国健康受试者空腹状态下单中心、随机、开放、双周期、双交叉设计的生物等效性试验
[Translation] A single-center, randomized, open-label, two-period, two-crossover design bioequivalence trial of febuxostat tablets in healthy Chinese subjects
1.主要目的:评价广东一力罗定制药有限公司生产的非布司他片(规格:40mg)与原研药非布司他片(规格:40mg,商品名:Uloric®,Takeda Pharmaceuticals America, Inc.生产)在健康成年受试者空腹状态下单次口服给药的人体生物等效性。 2.次要目的:评价非布司他片在健康成年受试者中的安全性。
[Translation] 1. Main purpose: to evaluate the febuxostat tablets (specification: 40mg) produced by Guangdong Yililuo Custom Pharmaceutical Co., Ltd. and the original research drug febuxostat tablets (specification: 40mg, trade name: Uloric®, Takeda Pharmaceuticals America, Inc. . production) human bioequivalence of a single oral dose in healthy adult subjects in the fasted state. 2. Secondary objective: To evaluate the safety of febuxostat tablets in healthy adult subjects.
100 Clinical Results associated with Yili Pharmaceutical Luoding Co., Ltd.
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