2
Clinical Trials associated with Mixed Protamine Human Insulin (30R)(HEC Pharm)一项比较精蛋白重组人胰岛素注射液(预混30R)和精蛋白生物合成人胰岛素注射液(预混30R)(诺和灵®30R)在健康受试者中的药代动力学和药效学特征的临床研究
[Translation] A clinical study comparing the pharmacokinetic and pharmacodynamic characteristics of protamine recombinant human insulin injection (premixed 30R) and protamine biosynthetic human insulin injection (premixed 30R) (Novolin® 30R) in healthy subjects
主要目的:以诺和诺德制药有限公司在中国上市的精蛋白生物合成人胰岛素注射液(预混30R)(诺和灵®30R)为对照药,评价单剂量皮下注射宜昌东阳光长江药业股份有限公司生产的精蛋白重组人胰岛素注射液(预混30R)在健康受试者中的药代动力学性质,并评价试验药物和对照药品的生物等效性。
次要目的:评价精蛋白重组人胰岛素注射液(预混30R)和诺和诺德制药有限公司在中国上市的精蛋白生物合成人胰岛素注射液(预混30R)(诺和灵®30R)在健康受试者中的安全性,并评估二者的药效学相似性。
[Translation] Primary objective: To evaluate the pharmacokinetic properties of a single subcutaneous injection of protamine recombinant human insulin injection (premixed 30R) produced by Yichang East Sunshine Changjiang Pharmaceutical Co., Ltd. in healthy subjects, using protamine biosynthetic human insulin injection (premixed 30R) (Novolin® 30R) marketed in China by Novo Nordisk Pharmaceuticals Co., Ltd. as the control drug, and to evaluate the bioequivalence of the test drug and the control drug.
Secondary objective: To evaluate the safety of protamine recombinant human insulin injection (premixed 30R) and protamine biosynthetic human insulin injection (premixed 30R) (Novolin® 30R) marketed in China by Novo Nordisk Pharmaceuticals Co., Ltd. in healthy subjects, and to evaluate the pharmacodynamic similarity between the two.
多中心、开放、随机、阳性药物平行对照试验,评价自研制剂在2型糖尿病患者中的有效性和安全性
[Translation] A multicenter, open, randomized, positive drug parallel controlled trial to evaluate the efficacy and safety of self-developed preparations in patients with type 2 diabetes
评价由宜昌东阳光长江药业股份有限公司生产的精蛋白重组人胰岛素注射液(预混30R)在2型糖尿病患者中的有效性和安全性。
[Translation] To evaluate the efficacy and safety of protamine recombinant human insulin injection (premixed 30R) produced by Yichang East Sunshine Changjiang Pharmaceutical Co., Ltd. in patients with type 2 diabetes.
100 Clinical Results associated with Mixed Protamine Human Insulin (30R)(HEC Pharm)
100 Translational Medicine associated with Mixed Protamine Human Insulin (30R)(HEC Pharm)
100 Patents (Medical) associated with Mixed Protamine Human Insulin (30R)(HEC Pharm)
100 Deals associated with Mixed Protamine Human Insulin (30R)(HEC Pharm)