Bioequivalence study of pregabalin capsules in Chinese healthy volunteers
10.13699/j.cnki.1001-6821.2024.24.020
- VernacularTitle:普瑞巴林胶囊在中国健康受试者体内的生物等效性研究
- Author:
Hao-yun XU
1
;
Jin-ling YI
;
Yi-li LIN
;
Wen-gang XIONG
;
Jian-feng LIU
Author Information
1. 厦门大学附属第一医院药物临床试验机构,福建厦门36100
- Publication Type:Journal Article
- Keywords:
pregabalin capsules;
ultra-high performance liquid chromatography-tandem mass spectrometry;
pharmacokinetic;
bioequivalence
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(24):3621-3625
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the pharmacokinetic characteristic and evaluate the bioequivalence of pregabalin capsules in healthy human plasma under fasting and fed conditions,between the test and reference formulations of pregabalin.Methods Twenty-four healthy volunteers were recruited for fasting and fed conditions,respectively,using single center,randomized,open,two-cycle,two-sequence,double-crossover design,a single oral dose of pregabalin capsule is administrated at 150 mg for test preparation(T)and reference preparation(R),and the washout period is 5 days.The concentration of pregabalin in plasma were determined by ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)platform.The pharmacokinetic parameters for each formulation were calculated by Phoenix WinNonlin version 8.0(Pharsight Corporation)using the non-atrioventricular model estimation and analysis,and the bioequivalence was evaluated in the study.Results The main pharmacokinetic parameters of a single oral pregabalin capsule under fasting condition for T and R were as follows:Cmax were(6 180.00±1 170.00)and(6 020.00±1 230.00)ng·mL-1;tmax were 0.75(0.50,1.25)and 0.75(0.50,2.00)h;t1/2 were(5.88±0.82)and(5.96±1.11)h;AUC0-t were(30 921.28±5 156.41)and(30 831.40±5 103.43)ng·mL-1·h.The 90％confidence interval for the geometric mean ratios of Cmax,AUC0-t and AUC0-∞ of T and R under fasting condition were 94.79％-110.42％,97.76％-102.87％and 97.13％-102.87％,respectively.The main pharmacokinetic parameters of a single oral pregabalin capsule under fed condition for T and R were as follows:Cmax were(3 430.00±399.00)and(3 460.00±444.00)ng·mL-1;tmax were 3.50(2.00,4.00)and 3.50(1.33,4.00)h;t1/2 were(6.06±0.96)and(6.06±1.06)h;AUC0-,were(28 999.76±3 309.61)and(29 210.75±3 121.60)ng·mL-1·h.The 90％confidence interval of Cmax,AUC0-t and AUC0-∞ of T and R under fed condition were 95.83％-102.98％,97.62％-100.83％and 97.33％-101.39％,respectively.Conclusion Under fasting and fed conditions,the pregabalin capsule test preparation and the pregabalin capsule reference preparation were bioequivalent in Chinese healthy subjects.
