Bioequivalence of levofloxacin dispersible tablets in healthy volunteers

Objective: To investigate the bioequivalence of levofloxacin lactate dispersible tablets in health volunteers.Methods: In a randomized cross-over trial,20 male healthy volunteers took a single oral dose of levofloxacin lactate(200 mg) of either test or reference dispersible tablets.The concentrations of levofloxacin in serum were determined by HPLC.Results: The main pharmacokinetic parameters of test or reference tablets were as follows: t1/2β(6.89±2.11) and(6.62±1.55)h;Tmax(0.74±0.30) and(1.11±0.59)h;Cmax(2.83±0.75) and(2.46±0.73) mg·L-1;AUC0～24 h(15.64±3.54) and(15.19±3.43)mg·L-1·h;AUC0～∞(17.15±4.34) and(16.75±4.29)mg·L-1·h.The average relative bioavailabilities calculated from AUC0～24 h and AUC0～∞ were(104.20±16.01)% and(104.25±18.83)%.The two tablets were bioequivalent as analyzed by two one-sided t-test for Cmax,AUC0-24 h and AUC0～∞ after logarithmic transformation.Conclusion: The two levofloxacin tablets are bioequivalent.