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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date25 Nov 1996 |
[Translation] Study on the bioequivalence of dopamine hydrazine tablets (0.25g) in human body
以重庆锐恩医药有限公司研制的多巴丝肼片(规格:0.25 g)为受试制剂,以持证商为上海罗氏制药有限公司的多巴丝肼片(商品名:美多芭®,规格:0.25 g)为参比制剂,考察两制剂在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。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] The dopamine tablets (specification: 0.25 g) developed by Chongqing Ruien Pharmaceutical Co., Ltd. were used as the test preparation, and the dopamine tablets (trade name: Madopar®, specification: 0.25 g) produced by Shanghai Roche Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after a single dose in the postprandial state were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.
[Translation] Study on the bioequivalence of dopamine tablets (0.25 g) in healthy volunteers
以重庆锐恩医药有限公司研制的多巴丝肼片(规格:0.25 g)为受试制剂,以持证商为上海罗氏制药有限公司的多巴丝肼片(商品名:美多芭®,规格:0.25 g)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。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] The dopamine tablets (specification: 0.25 g) developed by Chongqing Ruien Pharmaceutical Co., Ltd. were used as the test preparation, and the dopamine tablets (trade name: Madopar®, specification: 0.25 g) produced by Shanghai Roche Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations were investigated after single administration in the fasting and postprandial states to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.
100 Clinical Results associated with Chongqing Ruien Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Chongqing Ruien Pharmaceutical Co., Ltd.
100 Deals associated with Chongqing Ruien Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Chongqing Ruien Pharmaceutical Co., Ltd.