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Clinical Trials associated with Insulin human biosimilar(Ningbo Kunpeng Biotech)人胰岛素注射液在中国健康男性受试者中的随机、开放、单剂量皮下注射药代动力学及安全性的Ⅰ期临床研究
[Translation] A randomized, open-label, single-dose subcutaneous injection pharmacokinetics and safety phase I clinical study of human insulin injection in healthy Chinese male subjects
主要目的: 采用正葡萄糖钳夹技术,在健康男性受试者中比较宁波鲲鹏生物科技有限公司研制的人胰岛素注射液与优泌林®单剂量皮下注射药代动力学相似性; 采用正葡萄糖钳夹技术,在健康男性受试者中比较宁波鲲鹏生物科技有限公司研制的人胰岛素注射液与优泌林®单剂量皮下注射药效动力学相似性。
次要目的: 评价人胰岛素注射液在健康男性受试者中的安全性。
[Translation] Primary objective: To compare the pharmacokinetic similarity of human insulin injection developed by Ningbo Kunpeng Biotechnology Co., Ltd. and Humulin® single-dose subcutaneous injection in healthy male subjects using the euglycemic clamp technique; To compare the pharmacodynamic similarity of human insulin injection developed by Ningbo Kunpeng Biotechnology Co., Ltd. and Humulin® single-dose subcutaneous injection in healthy male subjects using the euglycemic clamp technique.
Secondary objective: To evaluate the safety of human insulin injection in healthy male subjects.
100 Clinical Results associated with Insulin human biosimilar(Ningbo Kunpeng Biotech)
100 Translational Medicine associated with Insulin human biosimilar(Ningbo Kunpeng Biotech)
100 Patents (Medical) associated with Insulin human biosimilar(Ningbo Kunpeng Biotech)
100 Deals associated with Insulin human biosimilar(Ningbo Kunpeng Biotech)