中国临床药理学与治疗学2017，Vol.22Issue(3)：294-298,5.
左乙拉西坦注射液与左乙拉西坦片在健康受试者中的药代动力学比较
Comparison of the pharmacokinetics of levetiracetam injection and levetiracetam tablets in human
摘要
Abstract
AIM:To compare the pharmacokinetic parameters of levetiracetam with those of levetiracetam tablets in fasting condition,and to observe the safety and tolerability of them in healthy subjects.METHODS:The concentrations of levetiracetam in plasma samples of healthy subjects before and after two cycles of administration were determined using established high performance liquid chromatography-mass spectrometry (HPLC-MS/MS) analysis.RESULTS:The main pharmacokinetic parameters of levetiracetam after intravenous injection and oral administration of levetiracetam were as follows:t1/2were (7.70±0.85),(7.81±0.88) h;Tmax were(0.70 ±0.10),(0.90 ±0.80)h,Cmax were (51.64±9.59),(40.83 ±9.13) ng/mL and AUC0-t were (385.69 ± 65.45),(394.24 ±64.68) ng · mL-1 · h,and AUC0-∞ was (390.85 ±66.40),(400.13±65.89) ng· mL-1 · h,respectively.The average relative bioavailability of the test preparation was (98.1 ± 9.4) ％ with levetiracetam AUC0-t.No severe adverse events were observed during the trial.CONCLUSION:The pharmacokinetic parameters of levetiracetam and levetiracetam tablets are not significantly different,and the safety is better in healthy subjects.关键词
左乙拉西坦/抗癫痫药物/HPLC-MS/MS/药代动力学/安全性评价Key words
levetiracetam/antiepileptic drugs/HPLC-MS/MS/pharmacokinetic/safety evaluation分类
医药卫生引用本文复制引用
刘史佳,陈都,殷俊刚,储继红,许美娟,刘芳,戴国梁,熊宁宁,居文政..左乙拉西坦注射液与左乙拉西坦片在健康受试者中的药代动力学比较[J].中国临床药理学与治疗学,2017,22(3):294-298,5.基金项目
国家自然科学基金青年科学基金项目(81403174) （81403174）
国家自然基金面上项目(81470197) （81470197）
江苏省自然基金面上项目(BK20151602,BK20161610) （BK20151602,BK20161610）
江苏省“六大人才高峰”高层次人才项目(WSN-051) （WSN-051）
江苏省青年医学人才(QNRC2016642) （QNRC2016642）
