普瑞巴林胶囊在中国健康受试者中的生物等效性研究OA

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.