/ CompletedNot Applicable 布瑞哌唑片在健康受试者中空腹及餐后状态下的随机、开放、两周期、双交叉生物等效性临床试验
[Translation] A randomized, open-label, two-period, double-crossover bioequivalence clinical trial of brepazole tablets in healthy subjects under fasting and fed conditions
主要目的:研究空腹及餐后状态下,单次口服布瑞哌唑片受试制剂(规格:2mg,扬子江药业集团南京海陵药业有限公司)与参比制剂(REXULTI®,规格:2mg,Otsuka Pharmaceutical Co., Ltd.)在健康受试者中的药代动力学行为,评价两种制剂的生物等效性。
次要目的:评价受试制剂和参比制剂(商品名:REXULTI®)在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetic behavior of the test formulation of brexpiprazole tablets (specification: 2 mg, Nanjing Hailing Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Group) and the reference formulation (REXULTI®, specification: 2 mg, Otsuka Pharmaceutical Co., Ltd.) in healthy subjects after a single oral administration under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations.
Secondary objective: To evaluate the safety of the test formulation and the reference formulation (trade name: REXULTI®) in healthy subjects.
/ CompletedNot Applicable 甲苯磺酸艾多沙班片在健康受试者中随机、开放、四周期、重复交叉空腹和餐后状态下生物等效性临床试验
[Translation] A randomized, open-label, four-period, repeated crossover bioequivalence clinical trial of edoxaban tosylate tablets in healthy subjects under fasting and fed conditions
主要目的:研究空腹或餐后状态下,单次口服甲苯磺酸艾多沙班片受试制剂(规格:60mg)与参比制剂(Lixiana®,规格:60mg,Daiichi Sankyo Europe GmbH)在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂和参比制剂(商品名:Lixiana®)在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetic behavior of the test formulation (specification: 60 mg) and the reference formulation (Lixiana®, specification: 60 mg, Daiichi Sankyo Europe GmbH) of edoxaban tosylate tablets in healthy subjects after a single oral administration in the fasting or postprandial state, and to evaluate the bioequivalence of the two formulations.
Secondary objective: To observe the safety of the test formulation and the reference formulation (trade name: Lixiana®) in healthy subjects.
/ CompletedNot Applicable 伏立康唑分散片在健康受试者中随机、开放、两周期、双交叉、空腹状态下生物等效性临床试验
[Translation] A randomized, open-label, two-period, double-crossover, fasting bioequivalence clinical trial of voriconazole dispersible tablets in healthy subjects
主要目的:在空腹状态下,以扬子江药业集团南京海陵药业有限公司生产的伏立康唑分散片(规格:200mg,)为受试制剂,以Pfizer Italia S.r.l.生产的伏立康唑片(威凡®,规格:200mg,)为参比制剂,对比两制剂在健康受试者体内的药代动力学特征,评价两种制剂的生物等效性。
次要目的:观察受试制剂和参比制剂(商品名:威凡®)在健康受试者中的安全性。
[Translation] Primary objective: In the fasting state, voriconazole dispersible tablets (specification: 200 mg,) produced by Nanjing Hailing Pharmaceutical Co., Ltd. of Yangtze River Pharmaceutical Group were used as the test preparation, and voriconazole tablets (Vifan®, specification: 200 mg,) produced by Pfizer Italia S.r.l. were used as the reference preparation to compare the pharmacokinetic characteristics of the two preparations in healthy subjects and evaluate the bioequivalence of the two preparations.
Secondary objective: To observe the safety of the test preparation and the reference preparation (trade name: Vifan®) in healthy subjects.
100 Clinical Results associated with Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.
0 Patents (Medical) associated with Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.
100 Deals associated with Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.
100 Translational Medicine associated with Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.