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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2015  >  33(1): 32-35

CHEN Renhai, HUANG Xiaoling, DENG Yifang, LIU Quanhai. Bioequivalence of levetiracetam extended-release tablets in Beagle dogs[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(1): 32-35. doi: 10.3969/j.issn.1006-0111.2015.01.008
Citation: CHEN Renhai, HUANG Xiaoling, DENG Yifang, LIU Quanhai. Bioequivalence of levetiracetam extended-release tablets in Beagle dogs[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(1): 32-35. doi: 10.3969/j.issn.1006-0111.2015.01.008
shu

Bioequivalence of levetiracetam extended-release tablets in Beagle dogs

doi: 10.3969/j.issn.1006-0111.2015.01.008

  • Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai 200437, China

  • Received Date: 2014-03-28
  • Rev Recd Date: 2014-09-17
  • Objective To study the bioequivalence of two kinds of levetiracetam extended-release tables including the reference 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.
  • [1] Cramer JA,Glassman M,Rienzi V.The relationship between poor medication compliance and seizures[J].Epilepsy Behav,2002,3(4):338-342.
    [2] Claxton AJ,Cramer J,Pierce C.A systematic review of the associations between dose regimens and medication compliance[J].Clin Ther,2001,23(8):1296-1310.
    [3] Bialer M.Extended-release formulations for the treatment of epilepsy[J].CNS Drugs,2007,21(9):765-774.
    [4] Sommerville KW.Bioequivalence in development of antiepileptic drugs[J].Epilepsy Res,2006,68(1):82-85.
    [5] 何小爱,刘 智,朱刚直.左乙拉西坦片在健康人体内的生物等效性研究[J].中国药房,2013,24(10):907-909.
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Bioequivalence of levetiracetam extended-release tablets in Beagle dogs

doi: 10.3969/j.issn.1006-0111.2015.01.008
  • Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai 200437, China
  • Received Date: 2014-03-28
  • Rev Recd Date: 2014-09-17

Abstract: Objective To study the bioequivalence of two kinds of levetiracetam extended-release tables including the reference 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.

CHEN Renhai, HUANG Xiaoling, DENG Yifang, LIU Quanhai. Bioequivalence of levetiracetam extended-release tablets in Beagle dogs[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(1): 32-35. doi: 10.3969/j.issn.1006-0111.2015.01.008
Citation: CHEN Renhai, HUANG Xiaoling, DENG Yifang, LIU Quanhai. Bioequivalence of levetiracetam extended-release tablets in Beagle dogs[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(1): 32-35. doi: 10.3969/j.issn.1006-0111.2015.01.008
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