[Translation] Study on the bioequivalence of omeprazole enteric-coated capsules in fasting volunteers
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] Omeprazole enteric-coated capsules provided by Yili Pharmaceutical (Luoding) Co., Ltd. were used as the test preparation. According to the relevant provisions of bioequivalence studies, the absorption rate and degree of the two preparations in healthy fasting human subjects were compared with those of the omeprazole enteric-coated capsules (trade name: Losec ®, reference preparation) produced by AstraZeneca AB to investigate the bioequivalence of the two preparations in humans. Secondary objective: 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] A single-center, randomized, open-label, two-period, double-crossover bioequivalence study of febuxostat tablets in Chinese healthy subjects in the postprandial state
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. Primary objective: To evaluate the bioequivalence of Febuxostat Tablets (Specification: 40 mg) produced by Guangdong Yililuo Pharmaceutical Co., Ltd. and the original Febuxostat Tablets (Specification: 40 mg, trade name: Uloric®, produced by Takeda Pharmaceuticals America, Inc.) in healthy adult subjects after a single oral administration 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, double-crossover bioequivalence trial of febuxostat tablets in Chinese healthy subjects under fasting condition
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. Primary objective: To evaluate the bioequivalence of Febuxostat Tablets (Specification: 40 mg) produced by Guangdong Yililuo Pharmaceutical Co., Ltd. and the original Febuxostat Tablets (Specification: 40 mg, trade name: Uloric®, produced by Takeda Pharmaceuticals America, Inc.) in healthy adult subjects after single oral administration under fasting condition. 2. Secondary objective: To evaluate the safety of Febuxostat Tablets in healthy adult subjects.
100 Clinical Results associated with Yili Pharmaceutical Luoding Co., Ltd.
0 Patents (Medical) associated with Yili Pharmaceutical Luoding Co., Ltd.
100 Deals associated with Yili Pharmaceutical Luoding Co., Ltd.
100 Translational Medicine associated with Yili Pharmaceutical Luoding Co., Ltd.