Evaluation of the pharmacokinetic and pharmacodynamic similarity of recombinant human insulin in healthy Chinese volunteers by eug-lycemic clamp technology
10.12092/j.issn.1009-2501.2025.03.011
- VernacularTitle:正葡萄糖钳夹技术评价人胰岛素注射液在中国健康受试者的药动学和药效学临床研究
- Author:
Qian ZHANG
1
;
Jingjing YANG
;
Juan WU
;
Qin ZHANG
;
Huiling QIN
;
Liang YU
;
Yijun DU
;
Wei HU
Author Information
1. 安徽医科大学第二附属医院药物临床试验研究中心,合肥 230061,安徽
- Publication Type:Journal Article
- Keywords:
euglycemic clamp;
pharmacokinetics;
pharmacodynamics;
similarity
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2025;30(3):385-391
- CountryChina
- Language:Chinese
-
Abstract:
AIM:To evaluate the pharmacokinet-ics(PK)and pharmacodynamics(PD)of two recom-binant human insulin injection by euglycemic clamp technology in healthy male subjects after a single subcutaneous injection.METHODS:We con-ducted a randomized,open-label,single dose,two period,crossover study.A total of 24 healthy male subjects were enrolled and randomized to receive single subcutaneous doses(0.2 U/kg)of the investi-gational products every period.The PK and PD characteristics were assessed by euglycemic clamp up to 14 hours after dosing.RESULTS:Euglycemic clamp technique was successfully established.C-peptide levels detected at each time point before and after administration indicated that endoge-nous insulin secretion was inhibited in the two groups after administration.The geometric mean ratio of Cmax and AUC0-tand 90％confidence interval(CI)of test preparation and reference preparation under fasting condition were in the range of 80.00％-125.00％.CONCLUSION:The human insulin produced by KP Biotech demonstrated similarity to the reference preparation Humulin? in PK and PD characteristics in healthy Chinese subjects.
