Study on bioequivalence of levofloxacin tablets in healthy volunteers

Objective To evaluate the relative bioavailability and bioequivalence of test levofloxacin tablets from different manufactures.Methods 18 male healthy volunteers orally took a single dose of 200 mg tablets in randamized self-crossover ways.The plasma concentration of levofloxacin was determined by RP-HPLC with fluorescent detector.Results The pharmacokinetic parameters of reference and test drugs were as follow : T_(max)(1.03±0.67) and(0.93±0.38)h;C_(max)(2363.29±552.13) and(2499.25±573.31) ng/ml;T_(1/2β)(5.57±0.92) and(6.04±0.55)h;MRT(7.77±1.14) and(8.02±0.68)h;AUC_((0→t))(13790.96±2171.28) and(13894.83±1873.47) ng·h·ml~(-1),respectively.The relative bioavailability of levofloxacin tablet was(99.40±9.70)%.There was no statistical difference between levofloxacin tablet in pharmacokinetic parameters(P0.05).Conclusion Two preparations of levofloxacin tablets are bioequivalence.