Pharmacokinetics, pharmacodynamics, and bioequivalence study of SciLin TMR recombinant human insulin injection preparation / 中华临床营养杂志

ABSTRACT

Objective To study the pharmacokinetics and pharmacodynamics of recombinant human insulin preparations SciLin TM R and Humulin (R) R,and to evaluate their bioequivalence in Chinese healthy volunteers.Methods In this positive control,single dose,open label,randomized cross-over study,20 male healthy volunteers were recruited from March to October 2007,and tested on two experimental days with an interval of 7-14 days.The volunteers were divided into two groups with a random number table,one group was injected with SciLin TMR for the first time and Humulin (R) R for the second time,the other group was injected with the opposite.The pharmacokinetics and pharmacodynamic properties were evaluated by euglycemic glucose clamp study.Results Time to peak concentration [Tmax,(105.8 ± 19.1) minutes vs.(103.5 ± 18.1) minutes,P =0.389) and time to maximum glucose infusion rate [TGIRmax,(132.8 ± 16.8) minutes vs.(132.8 ± 18.6) minutes,P =0.697] for SciLin TMR and Humulin(R) R were similar.The relative bioavailability of SciLin TMR was (102.2 ± 7.6) ％,and the relative biological effectiveness was (107.4 ± 18.8) ％.The 90％ confidence interval(CI) of peak concentration(Cmax) and area under the curve of blood glucose concentration at 0-10 hours (AUCIns 0-10) of SciLin TM R were 99.32 ％-102.62 ％ (equivalent range 70％-143 ％) and 98.98 ％-104.99 ％ (equivalent range 80％-125％),respectively;90％ CI of the maximum glucose infusion rate (GIRmax) and AUCGIR0-10 were 97.36％ ～ 103.49％ (equivalent range 70％-143％) and 98.72％-113.54％ (equivalent range 80％-125％),respectively,indicating that SciLin TMR and Humulin (R) R was bioequivalent.There was no clinically significant abnormalities in the safety indexes before and after the tests.During the trial,no hypoglycemic events,allergic reactions,or local injection adverse reaction occurred.Conclusion The studied recombinant human insulin preparation SciLin TMR may be bioequivalent as Humulin (R) R.