左乙拉西坦片在中国成年健康志愿者的生物等效性及安全性评价

发布时间：2018-03-24 21:05

  本文选题：左乙拉西坦　切入点：生物等效性　出处：《中国临床药理学杂志》2015年14期

【摘要】：目的探讨两种左乙拉西坦片在健康人体内的药代动力学行为,并评价两种制剂间的生物等效性。方法 20名健康成年男性受试者随机分为2组,每组10名,分别交叉单剂量口服左乙拉西坦片试验药物或参比药物0.5 g,2次给药间隔1周。用LC/MS/MS法测定血浆中左乙拉西坦浓度,用Win Nonlin 6.3计算药代动力学参数。结果受试者口服试验药物和参比药物后,左乙拉西坦的主要药代动力学参数如下:t1/2分别为(8.01±1.16),(8.02±0.93)h,tmax分别为(0.61±0.41),(0.76±0.61)h,Cmax分别为(13.65±2.63),(13.15±2.30)μg·m L-1,AUC0-t分别为(115.84±12.75),(119.29±15.29)μg·m L-1·h,AUC0-∞分别为(121.44±15.17),(124.89±16.73)μg·m L-1·h。试验药物和参比药物AUC0-t相对生物利用度是(97.55±7.06)%。试验期间未发生严重不良事件。结论受试药物和参比药物具有生物等效性。
[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 卤1.16 ~ (-1) h ~ (-1) C _ (max) = 0.61 卤0.41 ~ (-1) h ~ (-1) C _ (max) = 13.65 卤2.63 ~ (-1) 渭 g / m ~ (-1) ~ (-1) AUC0-t = 115.84 卤12.75 ~ (1.29) 渭 g / m ~ (-1) ~ (-1) 渭 g / m ~ (-1) AUC0- 鈭，

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