Bioequivalence study of buspirone hydrochloride tablets in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.05.019
- VernacularTitle:盐酸丁螺环酮片在中国健康受试者中的生物等效性研究
- Author:
Ping LU
1
;
Rui WANG
;
Hui-Hui WU
;
Hai-Yan LIU
;
Ge-Fei HE
;
Shun-Zhi ZHANG
;
Wei WU
Author Information
1. 长沙市第一医院、中南大学湘雅医学院附属长沙医院Ⅰ期临床研究中心,湖南长沙 410013
- Keywords:
buspirone hydrochloride tablet;
bioequivalence;
highly variable drug;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(5):723-727
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the pharmacokinetic characteristics of buspirone hydrochloride tablets in healthy adult populations under conditions of fasting and postprandial administration.Methods A single-center,randomized,three-cycle partially repeated crossover trial design was adopted,and 36 subjects were enrolled on fasting/postprandial,one tablet of the test preparation was taken in one cycle,one tablet of reference preparation(5 mg of buspirone tablets)was taken once in each of 2 cycles,the drug concentration of buspirone in plasma was determined by liquid chromatography-tandem mass spectrometry,and the pharmacokinetic parameters were calculated by WinNonlin software.Results Main pharmacokinetics of buspirone after oral administration of test and reference preparations in fasting group,the Cmax was(285.72±286.08)and(308.94±341.03)pg·mL-1;AUC0-t were(577.09±491.10)and(618.62±642.56)pg·mL-1·h;AUC0-∞ were(586.85±510.04)and(655.92±687.95)pg·mL-1·h;tmax was 0.75(0.33-4.00)and 0.75(0.33-1.75)h.Main pharmacokinetics of buspirone after oral administration of test and reference preparations in the postprandial group,the Cmax were(676.36±603.64)and(760.33±610.27)pg·mL-1;AUC0-t were(1 755.58±1 001.69)and(1 743.00±1 073.33)pg·h·mL-1;AUC0-∞ were(1 839.97±1 044.60)and(1 818.00±1 106.95)pg·mL-1·h;tmax was 1.25(0.25-4.50)and 1.00(0.25-3.50)h.The 90％confidence intervals of the AUC0-t and AUC0-∞ geometric mean ratios of the test preparation and the reference preparation in the fasting test and the postprandial test all fell between 80.00％and 125.00％,and the 95％upper confidence limit of of Cmax was ≤0 and geometric mean ratios point estimates fall between 80.00％and 125.00％.Conclusion Two kinds of buspirone hydrochloride are bioequivalent in Chinese healthy adult subject.
