本文選題：左乙拉西坦　切入點：生物等效性　出處：《中國臨床藥理學(xué)雜志》2015年14期

【摘要】：目的探討兩種左乙拉西坦片在健康人體內(nèi)的藥代動力學(xué)行為,并評價兩種制劑間的生物等效性。方法 20名健康成年男性受試者隨機分為2組,每組10名,分別交叉單劑量口服左乙拉西坦片試驗藥物或參比藥物0.5 g,2次給藥間隔1周。用LC/MS/MS法測定血漿中左乙拉西坦?jié)舛?用Win Nonlin 6.3計算藥代動力學(xué)參數(shù)。結(jié)果受試者口服試驗藥物和參比藥物后,左乙拉西坦的主要藥代動力學(xué)參數(shù)如下:t1/2分別為(8.01±1.16),(8.02±0.93)h,tmax分別為(0.61±0.41),(0.76±0.61)h,Cmax分別為(13.65±2.63),(13.15±2.30)μg·m L-1,AUC0-t分別為(115.84±12.75),(119.29±15.29)μg·m L-1·h,AUC0-∞分別為(121.44±15.17),(124.89±16.73)μg·m L-1·h。試驗藥物和參比藥物AUC0-t相對生物利用度是(97.55±7.06)%。試驗期間未發(fā)生嚴(yán)重不良事件。結(jié)論受試藥物和參比藥物具有生物等效性。
[Abstract]:Objective to investigate the pharmacokinetic behavior of two levoethylacetam tablets in healthy volunteers and to evaluate the bioequivalence between the two preparations. Methods Twenty healthy adult male subjects were randomly divided into two groups, 10 in each group. The concentration of levoethylacetam in plasma was determined by LC/MS/MS method. Win Nonlin 6.3 was used to calculate the pharmacokinetic parameters. The main pharmacokinetic parameters of levoethoxetam were as follows: t _ 1 / 2 = 8.01 鹵1.16 ~ (-1) h ~ (-1) C _ (max) = 0.61 鹵0.41 ~ (-1) h ~ (-1) C _ (max) = 13.65 鹵2.63 ~ (-1) 渭 g / m ~ (-1) ~ (-1) AUC0-t = 115.84 鹵12.75 ~ (1.29) 渭 g / m ~ (-1) ~ (-1) 渭 g / m ~ (-1) AUC0- 鈭，

本文編號：1660021