Chinese Journal of Pharmacovigilance ›› 2011, Vol. 8 ›› Issue (7): 385-387.

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The Bioavailability and Bioequivalence Analysis of Three Levornidazole Preparations in Healthy Volunteers

WANG XIAO-juan1, YUAN Hong2, SONG Min2, TAN Hong-yi2, HUANG Zhi-jun2, LIU Chang2, HUANG Yuan-yuan2, FU Zhi-min2, YANG Guo-ping2   

  1. 1.HuNan Food and Drug Vocational College, Hunan Changsha, 410000, China;
    2.The Third Xiangya Hospital of Central South University, Hunan Changsha 410000, China
  • Received:2011-02-21 Online:2011-07-10 Published:2015-07-13

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Abstract: Objective To study the pharmacokinetics and bioequivalence of three Levornidazole preparations in healthy volunteers. Methods The study was conducted in twenty-four healthy male volunteers. After receiving a single dose of 500 mg Levornidazole dispersible tablet, Levornidazole capsule and Levornidazole tablet(Reference) in three crossed way, the drug concentrations in plasma were determined by HPLC-UV method, the pharmacokinetic parameters and the statistical analysis of bioequivalence were obtained by DAS Ver 2.1. Results The pharmacokinetic parameters for Levornidazole dispersible tablet, Levornidazole capsule and the reference Levornidazole tablet were as follows: Cmax were (10.6±3.5), (10.4±3.7) and (11.1±3.3)mg·L-1, tmax were(0.76±0.70), (1.35±0.80) and (0.92±0.84)h, t1/2 were(13.2±1.4), (12.9±1.7) and (12.3±1.9)h, AUC0→48 were(140.7±31.3 ), (149.5±28.5) and (143.2±37.2)mg·L-1·h, AUC0→∞ were (152.6±33.4), (162.0±31.8) and (153.7±30.1)mg·L-1·h. By evaluating AUC0→48 and AUC0→∞, the relative bioavailability of Levornidazole dispersible tablet and capsule to the reference were (98.3±12.0)%, (99.5±12.1)% and (104.9±9.5)%, (106.0±10.5)% respectively. Conclusion Levornidazole dispersible tablet, capsule and the reference tablets were bioequivalent.

Key words: Levornidazole, pharmacokinetics, bioequivalence, HPLC-UV

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