|
|
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
|
|
|
|
|
Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项比较精蛋白人胰岛素混合注射液(30R)和精蛋白人胰岛素混合注射液(30R)(优泌林®70/30)在健康受试者中药代动力学和药效学特征的试验
[Translation] A trial comparing the pharmacokinetic and pharmacodynamic characteristics of protamine-human insulin mixture (30R) and protamine-human insulin mixture (30R) (Humulin® 70/30) in healthy subjects.
主要目的:预试验:以Lilly France 公司的精蛋白人胰岛素混合注射液(30R)(优泌林 ®70/30)为对照药物,考察单剂量腹部皮下注射恒敬合创生物医药(浙江) 有限公司的精蛋白人胰岛素混合注射液(30R)在健康受试者中的药代动力 学(PK)和药效动力学(PD)特征,以验证分析方法、评估试验药物的变异程度、优化采样时间,为正式临床试验提供参考依据。 正式试验:以Lilly France 公司的精蛋白人胰岛素混合注射液(30R)(优泌 林®70/30)为对照药物,考察单剂量腹部皮下注射恒敬合创生物医药(浙江) 有限公司的精蛋白人胰岛素混合注射液(30R)在健康受试者中的PK 和PD 特征,评价试验药物和对照药物的相似性。 次要目的:评价精蛋白人胰岛素混合注射液(30R)在健康受试者中的安全性。
[Translation] Primary Objective: Preliminary Study: Using Lilly France's protamine human insulin mixture injection (30R) (Humulin® 70/30) as a control, this study investigates the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of a single-dose subcutaneous abdominal injection of Hengjing Hechuang Biopharmaceutical (Zhejiang) Co., Ltd.'s protamine human insulin mixture injection (30R) in healthy subjects. The aim is to validate analytical methods, assess the variability of the investigational drug, optimize sampling time, and provide a reference for the formal clinical trial. Formal Study: Using Lilly France's protamine human insulin mixture injection (30R) (Humulin® 70/30) as a control, this study investigates the PK and PD characteristics of a single-dose subcutaneous abdominal injection of Hengjing Hechuang Biopharmaceutical (Zhejiang) Co., Ltd.'s protamine human insulin mixture injection (30R) in healthy subjects, and evaluates the similarity between the investigational drug and the control drug. Secondary Objective: To evaluate the safety of protamine human insulin mixture injection (30R) in healthy subjects.
100 Clinical Results associated with Hengjing Hechuang Biopharmaceutical Zhejiang Co., Ltd.
0 Patents (Medical) associated with Hengjing Hechuang Biopharmaceutical Zhejiang Co., Ltd.
100 Deals associated with Hengjing Hechuang Biopharmaceutical Zhejiang Co., Ltd.
100 Translational Medicine associated with Hengjing Hechuang Biopharmaceutical Zhejiang Co., Ltd.