非布司他片在健康受试者中空腹/餐后单次口服给药、随机、开放、两制剂、两周期、交叉生物等效性试验
[Translation] A single oral administration, randomized, open-label, two-formulation, two-cycle, crossover bioequivalence trial of Febuxostat Tablets in healthy subjects on an empty stomach or after a meal
主要目的:通过空腹/餐后正式试验研究,考察中国健康受试者在空腹/餐后条件下单剂量口服四川依科制药有限公司生产的非布司他片(规格:40mg)与持证商Teijin Pharma Limited的非布司他片(规格:40mg)后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:评价单剂量口服非布司他片(规格:40mg)受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Main purpose: Through a fasting/postprandial formal trial study, to investigate the oral administration of a single dose of Febuxostat tablets (specification: 40mg) produced by Sichuan Yike Pharmaceutical Co., Ltd. to Chinese healthy subjects under fasting/postprandial conditions and the efficacy of the licensed manufacturer. Teijin Pharma Limited's in vivo pharmacokinetic characteristics of febuxostat tablets (specification: 40 mg) to evaluate the bioequivalence of the two preparations.
Secondary purpose: To evaluate the safety of a single dose of oral febuxostat tablets (specification: 40 mg) test preparation and reference preparation in Chinese healthy subjects.
富马酸比索洛尔片在健康受试者中空腹/餐后单次口服给药、随机、开放、两序列、两周期、交叉生物等效性试验
[Translation] A randomized, open-label, two-sequence, two-cycle, crossover bioequivalence trial of bisoprolol fumarate tablets in healthy subjects after a single oral administration on an empty stomach or after a meal
主要研究目的: 评价中国健康受试者在空腹/餐后状态下单次口服四川依科制药有限公司生产的富马酸比索洛尔片(规格:5mg/片)与参比制剂富马酸比索洛尔片(规格:5mg/片;商品名:康忻®)后的体内药代动力学特征,评价两制剂的生物等效性。 次要研究目的:评价单次口服富马酸比索洛尔片(规格:5mg/片)受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Main research purpose: To evaluate the single oral administration of bisoprolol fumarate tablets (specification: 5 mg/tablet) produced by Sichuan Yike Pharmaceutical Co., Ltd. and the reference preparation bisoprolol fumarate in Chinese healthy subjects under fasting/postprandial conditions. The in vivo pharmacokinetic characteristics of Lorol tablets (specification: 5mg/tablet; trade name: Kangxin®) were evaluated to evaluate the bioequivalence of the two preparations. Secondary research purpose: To evaluate the safety of a single oral dose of bisoprolol fumarate tablets (specification: 5 mg/tablet) test preparation and reference preparation in Chinese healthy subjects.
地氯雷他定片在健康受试者中的单剂量、随机、开放、交叉、两制剂、两周期空腹和餐后人体生物等效性试验
[Translation] Single-dose, randomized, open-label, crossover, two-dose, two-period fasting and postprandial human bioequivalence studies of desloratadine tablets in healthy subjects
主要目的:以四川依科制药有限公司的地氯雷他定片(规格:5mg)为受试制剂,以Merck Sharp & Dohme B.V.(默沙东制药公司)的地氯雷他定片(商品名:恩理思®,规格:5mg)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
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: Desloratadine tablets (specification: 5mg) from Sichuan Yike Pharmaceutical Co., Ltd. were used as the test preparation, and desloratadine tablets (trade name: En Lisi®, specification: 5mg) is the reference preparation, and the bioequivalence of the two preparations in healthy human body is investigated according to the relevant provisions of the bioequivalence test.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Sichuan Yike Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Sichuan Yike Pharmaceutical Co., Ltd.
100 Deals associated with Sichuan Yike Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Sichuan Yike Pharmaceutical Co., Ltd.