Bioequivalence of levofloxacin tablets in healthy volunteers

Objective To evaluate the relative bioavailability and bioequivalence of levofloxacin tablets. Methods 18 male healthy volunteers orally took a single dose of 200mg tablets in randamized self-crossover ways .The plasma concentrations of levofloxacin were determined by RP-HPLC with fluorescent detector. Results The pharmacokinetic parameters of levofloxacin reference and test drug were as follows : t_ max (0.99±0.31) and (1.01±0.57) h;C_ max (1.73±0.50) and (1.68±0.39) μg·mL~ -1 ;t_ 1/2β (6.99±1.00) and (6.71±1.10) h;MRT (9.62±1.58) and (9.44±1.47) h; AUC_ (0→24) (12.46±1.69) and (12.05±1.75) μg·h·mL~ -1 , respectively .There was no statistical difference between the reference and the test levofloxacin tablet in pharmacokinetic parameters(P0.05).The relative bioavailability of levofloxacin tablet was (103.80±6.10)%. Conclusion The reference and the test levofloxacin tablets are bioequivalent.