Pharmacokinetics and bioequivalence of sparfloxacin tablets in healthy volunteers

Objective: To study pharmacokinetics of sparfloxacin after oral administration of sparfloxacin tablets and evaluate the bioequivalence of test and reference formulations.Methods: Twenty healthy volunteers were randomized into two groups.A single oral dose of sparfloxacin tablets 200 mg was given to volunteers in a two-period cross-over design test.Plasma concentrations of sparfloxacin were determined by HPLC method.The pharmacokinetic parameters of sparfloxacin test and reference formulations were statistically calculated and the bioequivalence was evaluated.Results: The main pharmacokinetic parameters of sparfloxacin test and reference formulations were as follows,t1/2(21.634±4.613) and(19.890±2.519) h,tmax(3.475±0.769) and(3.525±0.786) h,cmax(779.019±240.985) and(726.950±184.295) μg/mL,AUC0～72(16 824.627±3 550.309) and(16 586.509±3 178.872) μg·h·mL-1,AUC0～∞(18 719.118±3 717.480) and(18 128.478±3 403.917) μg·h·mL-1,respectively.Conclusion: The relative bioavailability of test formulation was(104.06±15.11)%.The two preparations are bioequivalent.