Bioequivalence of levetiracetam extended-release tablets in Beagle dogs
10.3969/j.issn.1006-0111.2015.01.008
- VernacularTitle:左乙拉西坦缓释片在Beagle犬中的生物等效性研究
- Author:
Renhai CHEN
1
;
Xiaoling HUANG
;
Yifang DENG
;
Quanhai LIU
Author Information
1. 中国医药工业研究总院上海医药工业研究院
- Keywords:
levetiracetam;
extended-release tablet;
bioequivalence
- From:
Journal of Pharmaceutical Practice
2015;(1):32-35
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the bioequivalence of two kinds of levetiracetam extended‐release tables including the ref‐erence product of Keppra XR in Beagle dogs .Methods Dogs were administrated orally with single dose of levetiracetam tablets (1 000 mg) .The concentration of levetiracetam in dog plasma was detected by LC‐MS/MS .All parameters of pharmacokinetics were performed by WinNonlin 5 .2 software .Results Main pharmacokinetic parameters of test and reference tablets were as follow :tmax were 1.67 h and 3 .0 h ,Cmax were 89 .50 μg/ml and 71 .18 μg/ml ,t1/2 were 3 .68 h and 3 .50 h ,AUC(0‐48) were 826 .57 μg?h/ml and 757 .84 μg?h/ml ,AUC(0‐∞ )were 826 .68 μg?h/ml and 757 .93 μg?h/ml .The relative bioavailability of test tablets was 109 .07% to reference products of Keppra XR .Conclusion Therefore ,the two kinds of levetiracetam extended‐release tablets were bioequivalent in Beagle dogs .
