Bioequivalence study of domestic mirabegron sustained release tablets in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.15.020
- VernacularTitle:米拉贝隆缓释片在中国健康受试者中的生物等效性研究
- Author:
Xiao-Lin DU
1
;
Tian-Mei LIU
;
Yi-Jing ZHU
;
Xiao LI
;
Xiao-Lan YONG
Author Information
1. 成都新华医院药学部,四川成都 610066
- Keywords:
mirabegron sustained release tablet;
bioequivalence;
pharmacokinetics;
safety;
liquid chromatography tandem mass spectrometry
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(15):2246-2250
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the bioequivalence of test and reference mirabegron sustained release tablets under fasting/postprandial conditions.Methods A randomized,open,single dose,four cycle,two sequence,self-crossover trial design was used.32 healthy subjects respectively for fasting and fed study were enrolled,who were randomized to a single oral dose of 50 mg of either reference or test preparation of mirabegron sustained release tablets.The plasma concentration of mirabegron in healthy subjects after oral administration was detected by liquid chromatography tandem mass spectrometry,and Phoenix WinNonlin 8.2 software was used to calculate pharmacokinetic parameters and perform bioequivalence analysis.Results Subjects received a single oral dose of the reference and test formulations of mirabegron.The main pharmacokinetic parameters of mirabegron in the fasting study were asfollows:Cmaxwere(43.91±21.40)and(40.82±24.94)ng·mL-1,AUC0-t were(464.45±149.01)and(452.67±157.63)h·ng·mL-1,AUC0-∞were(501.64±162.39)and(488.70±173.81)h·ng·mL-1.The main pharmacokinetic parameters of mirabegron in the fed study were as follows:Cmax were(16.90±8.94)and(16.90±9.66)ng·mL-1,AUC0-t were(247.09±82.53)and(243.22±78.20)h·ng·mL-1,AUC0-∞ were(269.58±86.52)and(265.66±81.89)h·ng·mL-1.The 90％confidence intervals for the geometric means of Cmax,AUC0-t and AUC0-∞ for reference and test preparations in the fasting and fed groups were in the range of 80.00％to 125.00％.Conclusions The test and reference formulation of mirabegron sustained release tablets were bioeguivalence.
