艾拉莫德片在健康人体的单中心、开放、随机、单剂量给药的生物等效性临床试验
[Translation] A single-center, open-label, randomized, single-dose bioequivalence clinical trial of iguratimod tablets in healthy humans
主要目的:
以四川国为制药有限公司生产的艾拉莫德片(25mg/片)为受试制剂,以海南先声药业有限公司生产的艾拉莫德片(25mg/片,艾得辛)为参比制剂,考察两制剂的生物等效性。
次要目的:
观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] main purpose:
Iguratimod tablets (25 mg/tablet) produced by Sichuan Guowei Pharmaceutical Co., Ltd. were used as the test preparation, and Iguratimod tablets (25 mg/tablet, Aidexin) produced by Hainan Xiancece Pharmaceutical Co., Ltd. were used as the reference preparation. Compare the preparations to examine the bioequivalence of the two preparations.
Secondary purpose:
Observe the safety of test and reference preparations in healthy subjects.
乌帕替尼缓释片的单中心、开放、随机、单剂量给药临床试验
[Translation] A single-center, open, randomized, single-dose clinical trial of upadatinib sustained-release tablets
以四川国为制药有限公司生产的乌帕替尼缓释片(15mg/片)为受试制剂,以 AbbVie Ireland NLB.V.公司生产的乌帕替尼缓释片(15mg/片)为参比制剂(商品名:瑞福®),考察两制剂的生物等效性。
[Translation] Take the upatinib sustained-release tablet (15mg/tablet) produced by Sichuan Guowei Pharmaceutical Co., Ltd. as the test preparation, and the upadatinib sustained-release tablet (15mg/tablet) produced by AbbVie Ireland NLB.V. Comparing preparations (trade name: Ruifu®), to investigate the bioequivalence of the two preparations.
罗沙司他胶囊的单中心、开放、随机、单剂量、两周期、双交叉设计试验
[Translation] A single-center, open, randomized, single-dose, two-period, double-crossover design trial of roxadustat capsules
主要目的:
以四川国为制药有限公司生产的罗沙司他胶囊(50mg/粒)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(50mg/粒)为参比制剂,考察两制剂的生物等效性。
次要目的:
考察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] main purpose:
Roxadustat Capsules (50 mg/capsule) produced by Sichuan Guowei Pharmaceutical Co., Ltd. was used as the test preparation, and Roxadustat Capsules (50 mg/capsule) produced by Fibrojin (China) Pharmaceutical Technology Development Co., Ltd. was used as the reference preparation. Compare the preparations to investigate the bioequivalence of the two preparations.
Secondary purpose:
Investigate the safety of the test preparation and reference preparation in healthy subjects.
100 Clinical Results associated with Sichuan Guowei Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Sichuan Guowei Pharmaceutical Co., Ltd.
100 Deals associated with Sichuan Guowei Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Sichuan Guowei Pharmaceutical Co., Ltd.