中国临床药理学杂志Issue(14)：1411-1414,4.DOI:10.13699/j.cnki.1001-6821.2015.14.017
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
Bioequivalence and safety evaluation of levetiracetam tablets in healthy volunteers
摘要
Abstract
Objective To study pharmacokinetic behaviors of the Chinese healthy volunteers and to evaluate the bioequivalence of two kinds of levetiracetam tablets.Methods Twenty healthy male volunteers were randomly divided into two groups, each group 10 cases, they were orally respectively administrated with single dose of treatment and reference preparations of levetiracetam ( each 0.5 g).The cleaning peri-od was one week.The concentration of levetiracetam in human plasma was measured by LC/MS/MS.Main pharmacokinetic parameters were calculated by using WinNonlin 6.3 software.Results Main pharmaco-kinetic parameters of test and reference preparation were as follow:t1/2 were(8.01 ±1.16), (8.02 ±0.93) h, tmax were (0.61 ±0.41), (0.76 ±0.61 ) h, Cmax were ( 13.65 ±2.63 ), ( 13.15 ±2.30 )μg・ mL-1 , AUC0-t were ( 115.84 ±12.75 ) , ( 119.29 ±15.29 )μg・ mL-1・ h,AUC0-∞ were ( 121.44 ±15.17 ) , ( 124.89 ±16.73 )μg・ mL-1・ h,respectively.The relative bioavailability of test prepara-tion was ( 97.55 ±7.06 )%.Conclusion Two kinds of levetiracetam tablets are bioequivalent.关键词
左乙拉西坦/生物等效性/安全性评价Key words
levetiracetam/bioequivalence/safety evaluation分类
医药卫生引用本文复制引用
王淑民,周辉,郭韶洁,武峰,倪四阳,赵秀丽,产运霞,耿玉先..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[J].中国临床药理学杂志,2015,(14):1411-1414,4.基金项目
国家科技重大专项课题“重大新药创制”专项基金资助项目 （）
