Pharmacokinetic study of Noiiglutide injection,INS068 injection and the compound preparation in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2023.23.023
- VernacularTitle:诺利糖肽注射液和INS068注射液及其复方制剂在健康受试者体内的药代动力学研究
- Author:
Xiao-Dong XING
1
;
Ji-Gang ZHANG
;
Kai SHEN
;
Ming-Jian ZHANG
;
Yi-Xin ZHA
;
Shu-Jing JIN
;
Mei XU
;
Wen-Yuan XUE
;
Xue-Ying DING
Author Information
1. 上海交通大学医学院附属第一人民医院临床研究中心,上海 200080
- Keywords:
noiiglutide injection;
INS068 injection;
HR17031 injection;
pharmacokinetics;
drug-drug interaction
- From:
The Chinese Journal of Clinical Pharmacology
2023;39(23):3449-3454
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the pharmaceutics and drug interactions of noiiglutide injection,INS068 injection,HR17031 Injection,and noiiglutide+INS068 injection in healthy subjects Methods This was a single center,randomized,open-label,4-cycle,4-cohort trial.Healthy subjects were allocated to 4 groups randomly.HR17031(17 U/0.04 mg),INS068(17 U),noliglycopeptide(0.04 mg),and INS068(17 U)combined with noiiglutide(0.04 mg)were injected subcutaneously into the abdomenon on day 1,8,15 and 22 respectively.Venous blood was collected at different timing before and after administration,and the concentrations of noiiglutide in plasma and INS068 in serum were measured by HPLC-MS/MS method.Relevant pharmacokinetic parameters were calculated using the WinNonlin non compartment model.Results In HR17031,INS068,and INS068 combined with noiiglutide groups,the main pharmacokinetic parameters of INS068 in serum were calculated and listed as follows:Cmax were(19.50±4.06),(18.10±4.56)and(18.40±5.81)ng·mL-1,tmax was 12,10 and 8 h,t1/2 was(9.27±1.70),(11.00±2.81)and(11.0±3.18)h,AUC0-twere(505.00±62.20),(498.00±70.50)and(491.00±74.20)ng·mL-1·h.In HR17031,noiiglutide,and INS068 combined with noiiglutide groups,the main pharmacokinetic parameters of noiiglutide in plasma were calculated and listed as follows:Cmax were(3.61±0.82),(4.63±0.87)and(4.54±0.86)ng·mL-1,tmax was all 8.00 h,t1/2 was(10.50±1.61),(9.49±1.40)and(9.55±1.61)h,AUC0-twere(94.30±20.10),(106.00±20.20)and(105.00±19.00)ng·mL-1·h.Conclusion There was no significant difference in bioavailability of INS068 and noiiglutide in HR17031 compared with INS068 and noiiglutide whether combined or used alone.
