/ CompletedNot Applicable 盐酸丙卡特罗片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 Procaterol hydrochloride tablets in Chinese healthy subjects after single administration under fasting and fed conditions
主要目的:以持证商为OTSUKA PHARMACEUTICAL Co.,Ltd的盐酸丙卡特罗片(商品名:Meptin-mini,规格:25μg)为参比制剂,以青岛国大药业有限公司研制的盐酸丙卡特罗片(规格:25μg(按C16H22N2O3.HCl.1/2H2O计))为受试制剂,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:评价受试制剂与参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the two preparations in fasting and fed conditions in healthy Chinese subjects, using Procaterol Hydrochloride Tablets (trade name: Meptin-mini, specification: 25μg) from OTSUKA PHARMACEUTICAL Co., Ltd as the reference preparation and Procaterol Hydrochloride Tablets (specification: 25μg (calculated as C16H22N2O3.HCl.1/2H2O)) developed by Qingdao Guoda Pharmaceutical Co., Ltd. as the test preparation.
Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects.
100 Clinical Results associated with Qingdao Guoda Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Qingdao Guoda Pharmaceutical Co., Ltd.
100 Deals associated with Qingdao Guoda Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Qingdao Guoda Pharmaceutical Co., Ltd.