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Clinical Trials associated with Insulin aspart biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)A Glucose Clamp Trial Investigating The Biosimilarity of Gan & Lee Insulin Aspart Injection (Insulin Aspart 100 U/ml) With US and EU Insulin Aspart Comparator Products (NovoLog®/NovoRapid®) in Healthy Male Subjects
Primary objective:
To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Aspart Injection with both EU-approved NovoRapid® and US-licensed NovoLog® (Reference Products) in healthy male subjects
Secondary objectives:
To compare the PK and PD parameters of the three insulin aspart preparations
To evaluate the single dose safety and local tolerability of the three insulin aspart preparations
以进口同类产品(诺和锐50)为交叉对照,评价门冬胰岛素50(锐秀霖50)对健康受试者的生物等效和安全性
[Translation] Using an imported similar product (NovoRapid 50) as a cross-reference, the bioequivalence and safety of insulin aspart 50 (Rapid 50) in healthy subjects were evaluated
通过葡萄糖钳夹试验,比较锐秀霖50和诺和锐50在药代动力学和药效动力学的生物等效性
[Translation] Comparison of the pharmacokinetics and pharmacodynamics of Resoluline 50 and NovoRapid 50 using a glucose clamp test
多中心、随机比较进口同类产品(诺和锐)与门冬胰岛素(锐秀霖)联合二甲双胍治疗糖尿病的有效性和安全性
[Translation] A multicenter, randomized comparison of the efficacy and safety of an imported similar product (NovoRapid) and insulin aspart (Radoxil) combined with metformin in the treatment of diabetes mellitus
主要目的:根据HbA1c的情况,判断锐秀霖是否疗效非劣于诺和锐;次要目的:比较锐秀霖治疗组和诺和锐治疗组与基线相比达到目标HbAlc<7.0%,和≤6.5%的受试者百分比、餐后2h血糖及空腹血糖的变化等
[Translation] Primary purpose: To determine whether the efficacy of Resolv is non-inferior to that of NovoRapid based on the HbA1c situation; Secondary purpose: To compare the percentage of subjects reaching the target HbAlc <7.0% and ≤6.5% in the Resolvv and NovoRapid treatment groups compared with baseline, and the changes in 2h postprandial blood glucose and fasting blood glucose, etc.
Start Date- |
Sponsor / Collaborator- |
100 Clinical Results associated with Insulin aspart biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)
100 Translational Medicine associated with Insulin aspart biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)
100 Patents (Medical) associated with Insulin aspart biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)
100 Deals associated with Insulin aspart biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)