呋塞米片(20mg)在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验
[Translation] A human bioequivalence clinical trial of furosemide tablets (20 mg) in Chinese healthy subjects in the fasting and fed state after single administration
主要目的:以持证商为Validus Pharmaceuticals LLC 的呋塞米片(商品名:LASIX,规格:20mg)为参比制剂,以汇禹远和(海南)药业有限公司研制的呋塞米片(20mg)为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两周期、两序列、交叉设计的临床试验来评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: Using furosemide tablets (trade name: LASIX, specification: 20 mg) from Validus Pharmaceuticals LLC as the reference preparation and furosemide tablets (20 mg) developed by Huiyuyuanhe (Hainan) Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-cycle, two-sequence, crossover clinical trial was conducted to evaluate the bioequivalence of the two preparations in fasting and fed states in healthy Chinese subjects.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
100 Clinical Results associated with Huiyu Yuanhe (Hainan) Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Huiyu Yuanhe (Hainan) Pharmaceutical Co., Ltd.
100 Deals associated with Huiyu Yuanhe (Hainan) Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Huiyu Yuanhe (Hainan) Pharmaceutical Co., Ltd.