/ CompletedNot Applicable 甲磺酸溴隐亭片(2.5mg)在健康受试者中餐后状态下单次口服给药、随机、开放、两制剂、四周期、完全重复交叉生物等效性试验
[Translation] A randomized, open-label, two-formulation, four-period, fully replicated crossover bioequivalence trial of bromocriptine mesylate tablets (2.5 mg) in healthy subjects after a single oral dose in a postprandial setting.
主要目的:考察中国健康受试者在餐后状态下单剂量口服广州大光制药有限公司生产的甲磺酸溴隐亭片(规格:2.5mg)与持证商为Bridging Pharma GmbH的甲磺酸溴隐亭片(规格:2.5mg)(商品名:Parlodel®)的体内药代动力学特征,评价其两制剂的生物等效性。
次要目的:评价单次口服甲磺酸溴隐亭片(规格:2.5mg)受试制剂及参比制剂在中国健康受试者中的安全性
[Translation] Primary Objective: To investigate the pharmacokinetic characteristics of a single oral dose of bromocriptine mesylate tablets (2.5 mg) manufactured by Guangzhou Daguang Pharmaceutical Co., Ltd., and bromocriptine mesylate tablets (2.5 mg) (trade name: Parlodel®) manufactured by Bridging Pharma GmbH, in healthy Chinese subjects after a meal, and to evaluate their bioequivalence.
Secondary Objective: To evaluate the safety of a single oral dose of bromocriptine mesylate tablets (2.5 mg) in healthy Chinese subjects, both the test and reference formulations.
/ CompletedNot Applicable 多替诺雷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、双交叉生物等效性研究
[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of a single oral dose of dotinorel tablets in healthy volunteers after fasting or feeding
主要目的:考察中国健康受试者在空腹/餐后条件下单剂量口服广州大光制药有限公司生产的多替诺雷片(规格:2mg)与持证商为株式会社富士薬品的多替诺雷片(商品名:URECE®,规格:2mg)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:评价单剂量口服多替诺雷片(规格:2mg)受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] The primary objective was to investigate the in vivo pharmacokinetic characteristics of a single oral dose of 2 mg polytinol tablets manufactured by Guangzhou Daguang Pharmaceutical Co., Ltd. and a 2 mg polytinol tablets manufactured by Fuji Pharmaceutical Co., Ltd. (trade name: URECE®) under fasting and fed conditions in healthy Chinese volunteers, and to evaluate the bioequivalence of the two formulations.
The secondary objective was to evaluate the safety of a single oral dose of the test and reference formulations of 2 mg polytinol tablets in healthy Chinese volunteers.
/ CompletedNot Applicable 维立西呱片在健康参与者中随机、开放、两制剂、单次给药、两周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of Vericiguat tablets in healthy participants under fasting and fed conditions
主要目的:以广州大光制药有限公司研制的维立西呱片为受试制剂,以Bayer AG生产的维立西呱片(商品名:Verquvo®/郁可同®)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。次要目的:评价中国健康参与者单次空腹/餐后口服维立西呱片受试制剂和参比制剂后的安全性。
[Translation] The primary objective was to investigate the pharmacokinetic parameters and relative bioavailability of Vericigum tablets (developed by Guangzhou Daguang Pharmaceutical Co., Ltd.) as the test formulation and Vericigum tablets (trade name: Verquvo®/Yu Ke Tong®) produced by Bayer AG as the reference formulation after single-dose administration of the two formulations in the fasting and fed states, and to evaluate their bioequivalence. The secondary objective was to evaluate the safety of the test and reference formulations of Vericigum tablets in healthy Chinese participants after single oral administration in the fasting and fed states.
100 Clinical Results associated with Guangzhou Daguang Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Guangzhou Daguang Pharmaceutical Co., Ltd.
100 Deals associated with Guangzhou Daguang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Guangzhou Daguang Pharmaceutical Co., Ltd.