Pharmacokinetics of recombined human glucagonlike peptide-1(7-36) in Chinese healthy volonteers

Objective To investigate the pharmacokinetics of recombined human glucagon-like peptide-1(7-36) rhGLP-1(7-36) after subcutaneous injection in single dose and multidose in Chinese healthy volunteers. Methods The drug concentration of plasma sample from 12 volunteers after single dose subcutaneous injection 0.1,0.15, 0.2 mg rhGLP-1(7-36) was determined by enzyme linked immunosorbent assay(ELISA) method. The drug concentration of plasma sample from 9 volunteers after multidose subcutaneous injection 0.2mg 5min before meal 3 times per day and 5 days total was determined by ELISA method. The pharmacokinetic parameters were calculated by DAS software.Results The plasma concentration time curve fits one compartment model after single time subcutaneous injection rhGLP-1(7-36) 0.1,0.15,0.2 mg.The C_ max ,AUC_ 0-t increased along with the dose.The t_ max was 19 ~ 21min approximately; t_ 1/2 was 10 ~ 14 min. The main pharmacokinetic parameters of the first time and the last time of the fifth day after muti-dose subcutaneous rhGLP-1(7-36)C_ max was(726.76±94.07),(737.15± 72.12 ) ng·L~ -1 ; t_ max was (18.33±2.50) min; t_ 1/2 was 15～17 min.Conclusion The pharmacokinetics of the drug in the dosage range of 0.1~0.2 mg in human body nearly fit one grade linear dynamic feature. The pharmacokinetic parameters of drug subcutaneous injection 5 min before meal 3 times 5 day were not changed with no accumulation nor sevare ad-dictive effect.