/ CompletedNot Applicable 巴瑞替尼片在中国健康受试者中餐后状态下单次给药的人体生物等效性预试验
[Translation] A preliminary human bioequivalence study of baricitinib tablets in Chinese healthy volunteers after a single dose in the fed state
主要目的:以海南盈达润泽药业有限公司的巴瑞替尼片(规格:2mg)为受试制剂,以(持证商)Eli Lilly Nederland B.V.的巴瑞替尼片(商品名:艾乐明®OLUMIANT®,规格:2mg)为参比制剂,评价在中国健康受试者中餐后状态下两种制剂的生物等效性。
次要目的:观察在中国健康受试者中受试制剂和参比制剂的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of baricitinib tablets (specification: 2 mg) of Hainan Yingda Runze Pharmaceutical Co., Ltd. as the test preparation and baricitinib tablets (trade name: OLUMIANT®, specification: 2 mg) of Eli Lilly Nederland B.V. (licensed manufacturer) as the reference preparation in healthy Chinese subjects in the postprandial state.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
/ CompletedNot Applicable 随机、开放、单剂量、两制剂、自身交叉对照设计,评价中国健康受试者在空腹状态下使用外用制剂妥洛特罗贴剂的生物等效性正式试验
[Translation] A randomized, open-label, single-dose, two-drug, self-crossover controlled study to evaluate the bioequivalence of tulobuterol patch in Chinese healthy subjects in the fasting state
主要目的:以海南盈达润泽药业有限公司提供的妥洛特罗贴剂为受试制剂,按生物等效性试验的有关规定,与ヴィアトリス製薬株式会社持证的妥洛特罗贴剂(商品名:Hokunalin®,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。
[Translation] Main purpose: Taking the tuloterol patch provided by Hainan Yingda Runze Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, it will be compared with the certified tuloterol patch produced by Biotech Co., Ltd. (Trade name: Hokunalin®, reference preparation) Compare the absorption speed and degree of absorption in healthy humans to examine the human bioequivalence of the two preparations.
100 Clinical Results associated with Hainan Yingda Runze Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hainan Yingda Runze Pharmaceutical Co., Ltd.
100 Deals associated with Hainan Yingda Runze Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hainan Yingda Runze Pharmaceutical Co., Ltd.