中国临床药理学杂志2026，Vol.42Issue(8)：1176-1181,6.DOI:10.13699/j.cnki.1001-6821.2026.08.020
普瑞巴林胶囊在中国健康受试者中的生物等效性研究
Bioequivalence study of pregabalin capsules in Chinese healthy subjects
摘要
Abstract
Objective To study the bioequivalence of test preparation and reference preparation of pregabalin capsule in Chinese healthy subjects under fasting and fed conditions.Methods Using a single center,randomized,open,two cycle crossover design,52 healthy subjects were divided into fasting group and fed group,with 26 cases in each group.The test or reference preparation of pregabalin capsules was orally administered 150 mg once.The blood concentration was determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS)and pharmacokinetic(PK)parameters were calculated to evaluate the bioequivalence.Results The main PK parameters Cmax of pregabalin capsule test preparation and reference preparation in the fasting group were(6 722.00±1 390.00)and(6 065.00±1 218.00)ng·mL-1,respectively;AUC0-t were(32 570.52±3 877.48)and(32 721.93±4 270.54)ng·h·mL-1,respectively;AUC0-∞ were(32 941.98±4 040.07)and(33 097.11±4 428.89)ng·h·mL-1,respectively;tmax was 0.75(0.50,1.75)and 1.00(0.50,1.75)h,respectively;the t1/2 were(5.58±0.74)and(5.55±0.80)h,respectively.The main PK parameters Cmax of the test preparation and reference preparation of pregabalin capsules in the fed group were(3 786.00±513.90)and(3 786.00±437.50)ng·ml-1,respectively;AUC0-t were(32 760.51±4 250.79)and(31 923.83±3 842.92)ng·h·mL-1,respectively;AUC0-∞ were(33 371.21±4 406.02)and(32 519.87±4 050.39)ng·h·mL-1,respec tively;tmax was 3.50(2.50,4.50)and 3.00(2.50,4.51)h,respectively;the t1/2 was(5.95±0.79)and(5.89±0.91)h,respectively.Under fasting or fed conditions,the 90％confidence intervals of the main PK parameters of the test preparation and the reference preparation were both 80.00％-125.00％.Conclusion The test preparation and reference preparation of pregabalin capsules are bioequivalent under fasting and fed conditions.关键词
普瑞巴林胶囊/生物等效性/药代动力学/液相色谱—串联质谱法Key words
pregabalin capsule/bioequivalence/pharmacokinetics/liquid chromatography-tandem mass spectrometry method分类
医药卫生引用本文复制引用
何云山,周建军,何草芳,李牛秀..普瑞巴林胶囊在中国健康受试者中的生物等效性研究[J].中国临床药理学杂志,2026,42(8):1176-1181,6.基金项目
湖南省自然科学基金资助项目(2025JJ70595) （2025JJ70595）
