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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2017, Vol. 22 ›› Issue (3): 294-298.

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Comparison of the pharmacokinetics of levetiracetam injection and levetiracetam tablets in human

LIU Shijia 1, CHEN Du 2, YIN Jungang 1, CHU Jihong 1, XU Meijuan 1, LIU Fang 1, DAI Guoliang 1, XIONG Ningning 1, JU Wenzheng 1   

  1. 1 Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, Jiangsu, China; 2 China Pharmaceutical University, Nanjing 211198, Jiangsu, China
  • Received:2016-11-30 Revised:2017-02-06 Online:2017-03-26 Published:2017-03-29

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:t1/2 were (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.

Key words: levetiracetam, antiepileptic drugs, HPLC-MS/MS, pharmacokinetic, safety evaluation

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