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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2000, Vol. 5 ›› Issue (4): 333-335.

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Relative bioavailability of levofloxacin hydrohloride capsule in healthy volunteers

MA Yue-Ming, ZHENG Zao-Ho ng1, CHEN Bo1, MAO Guo-Guang1, ZHONG Qiu1, YAN Wen-Kui1, ZHA Xiao-Juan1, SUN Rui-Yuan   

  1. Department of Pharmacology, Wannan Medical College, Wuhu, 241001;
    1Institute of Clinical Medicine, Yijishan Hospital ,Wannan Medical College, Wuhu 241001
  • Received:2000-05-18 Revised:2000-07-05 Online:2000-12-26 Published:2020-11-27

Abstract: Aim To investigate the pharmacokinetics and relative bioavailability of levofloxacin hydrochloride capsule.Methods A single 200 mg oral dose of either capsule or tablet was given to 12 healthy male volunteers in randomized self-crossover way.Plasma levofloxacin concentration was determined by high performance liquid chromatography.The concentration-time data of levofloxacin was fit ted to two-compartment model with first-order absorption and the bioequivalence of the two formulations were evaluated by the analysis of variance and the two one-sidedt-test.Results The pharmacokinetic parameters were as follows: capsule:Cmax=(3.18±0.57)mg · L-1, tmax=(0.83±0.33)h, AUC0~24=(19.95±2.86)mg·h·L-1, t1/2(β)=(7.75±2.04)h ;tablet:Cmax=(2.96±0.43)mg·L-1, tmax=(0.96±0.33)h, AUC0~24=(21.49±1.88)mg ·h·L-1, t1/2(β)=(6.82±0.84)h.Relative bioavailability of capsule was (93.0±11.8)% compared with tablet.Conclusion The two formulations are of bioequivalence.

Key words: levofloxacin hydrochloride, pharmacokinetics, bio availability, HPLC

CLC Number: