Studies on bioequivalence of levofloxacin hydrochloride capsule in healthy volunteers

0bjective:To study the bioequivalence of two Levofloxacin capsules in healthy volunteers.Methods:A single oral dose of 200mg test or reference preparations was given to 18 healthy male volunteers in a randomized crossover study.The serum concentration of Levofloxacin was determined by HPLC with the fluorescence detector.The pharmacokinetic parameters and the relative bioavailability were calculated by DAS to evaluate the bioequivalence.Results:The main pharmacokinetic parameters of test and reference preparations were as follow:Cmax(3.206±0.498)μg/ml and(3.255±0.436)μg/ml;tmax(0.931±0.307)h and(0.903±0.322)h;AUC0~36(23.780±4.986)(μg.h)/ml and(23.934±5.625)(μg.h)/ml;AUC0~∞(24.510±5.189)(μg.h)/ml and(24.684±5.973)(μg.h)/ml,respectively.The relative bioavailability of the test capsule to the reference one was(103.9±29.1)%.Conclusion:The results of statistic analysis showed that the test and reference Levofloxacin hydrochloride capsules were bioequivalent.