[Translation] Study on the bioequivalence of Cinipride tartrate tablets in healthy volunteers
以中国健康受试者为试验对象,采用自身交叉对照的试验设计,测定安徽益普克医药科技发展有限公司持证的酒石酸西尼必利片给药后血浆中的西尼必利在健康受试者体内的血药浓度经时过程,估算相应的药代动力学参数,并以Almirall, S.A.持证生产的酒石酸西尼必利片【商品名:希笛尼(Cidine)®,规格:1mg(按西尼必利计)】为参比,评价制剂间的生物等效性,并观察酒石酸西尼必利片在中国健康受试者中的安全性。
[Translation] Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of plasma concentration of Cinipride in healthy subjects after administration of Cinipride Tartrate Tablets licensed by Anhui Yipke Pharmaceutical Technology Development Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Cinipride Tartrate Tablets licensed by Almirall, S.A. [Trade name: Cidine®, specification: 1 mg (calculated as Cinipride)] were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of Cinipride Tartrate Tablets in healthy Chinese subjects.
[Translation] Study on the bioequivalence of Cinipride tartrate tablets in healthy volunteers
以中国健康受试者为试验对象,采用自身交叉对照的试验设计,测定安徽益普克医药科技发展有限公司持证的酒石酸西尼必利片给药后血浆中的西尼必利在健康受试者体内的血药浓度经时过程,估算相应的药代动力学参数,并以Almirall, S.A.持证生产的酒石酸西尼必利片【商品名:希笛尼(Cidine)®,规格:1mg(按西尼必利计)】为参比,评价制剂间的生物等效性,并观察酒石酸西尼必利片在中国健康受试者中的安全性。
[Translation] Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of plasma concentration of Cinipride in healthy subjects after administration of Cinipride Tartrate Tablets licensed by Anhui Yipke Pharmaceutical Technology Development Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Cinipride Tartrate Tablets licensed by Almirall, S.A. [Trade name: Cidine®, specification: 1 mg (calculated as Cinipride)] were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of Cinipride Tartrate Tablets in healthy Chinese subjects.
100 Clinical Results associated with An Hui Yi Pu Ke Yi Yao Ke Ji Fa Zhan You Xian Gong Si
0 Patents (Medical) associated with An Hui Yi Pu Ke Yi Yao Ke Ji Fa Zhan You Xian Gong Si
100 Deals associated with An Hui Yi Pu Ke Yi Yao Ke Ji Fa Zhan You Xian Gong Si
100 Translational Medicine associated with An Hui Yi Pu Ke Yi Yao Ke Ji Fa Zhan You Xian Gong Si