Bioequivalence study of vildagliptin tablets under postprandial condition in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.21.016
- VernacularTitle:维格列汀片在中国健康受试者的餐后生物等效性研究
- Author:
Hui-min TANG
1
;
Zhong-qi YANG
;
Ya-qin TANG
;
Cheng CHENG
;
Qin ZHANG
;
Yan-jun WEI
;
Yan-ping DU
;
Jian-hua ZHU
;
Xiao-chuan LI
;
Yan LING
Author Information
1. 广州中医药大学第一附属医院Ⅰ期临床研究病房,广东 广州 510000;广东省中医临床研究院,广东 广州 510000
- Publication Type:Journal Article
- Keywords:
vildagliptin;
postprandial;
bioequivalence;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(21):3147-3152
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the pharmacokinetic(PK)characteristics,bioequivalence and safety of two kinds of vildagliptin tablets in Chinese healthy subjects in postprandial state.Methods A single-center,open,balanced,randomized,single-dose,two-period,two-sequence,crossover design was adopted.Each period,subjects orally took 50 mg of the test formulation or reference formulation after a high-fat meal.Blood samples were collected at preset time points and the plasma concentration of vildagliptin was measured by liquid chromatography/mass spectrometry(LC-MS/MS).The PK parameters were calculated using Phoenix WinNonlin 8.2 software;and the bioequivalence of the two formulations was evaluated.Demographic and baseline characteristics,as well as safety analysis of the subjects,were performed using SAS 9.4 software.Results Out of 24 subjects,one subject withdrew from the trial before administration in the first period,and another withdrew before administration in the second period.Under postprandial conditions,the main pharmacokinetic parameters of vildagliptin tablets for the test and reference formulations were Cmax were(230±73.9)and(203±44.0)ng·mL-1,AUC0-t were(1 065.93±215.46)and(1 029.30±185.78)ng·h·mL-1,AUC0-∞ were(1 078.74±217.93)and(1 041.59±190.66)ng·h·mL-1.The 90％confidence intervals for the geometric mean ratios of Cmax,AUC0-t and AUC0-∞ were within the requirements of the equivalent range of bioequivalence(80.00％-125.00％).During the trial,five subjects experienced mild adverse events,with no serious adverse events occurring.Conclusion Two kinds of vildagliptin tablets have bioequivalence in postprandial state,and have good safety and tolerability in healthy subjects.
