Pharmacokinetics and bioequivalence evaluation of Gatifloxacin Capsules

Objective:To evaluate the pharmacokinetics and bioequivalence of Gatifloxacin Capsules in the healthy male.Methods:40 healthy male were randomly divided into two groups,there were respectively given domestic and imported oral Gatifloxacin Capsules,used the high performance liquid chromatography method for detected the Gatifloxacin concentrations in plasma,and analyzed the major drug pharmacokinetic parameters and evaluated the bioequivalence of two formulations.Results:The oral administration of domestic and imported in the two groups after gatifloxacin′s half-life,peak time,peak concentration and the lag time had not significant different.Bioequivalence compared with the same time had no significant difference,so we thought that the two formulations were bioequivalent.Conclusion:Domestic and imported Gatifloxacin Capsules preparation or reference test preparation in healthy volunteers are bioequivalent and similar pharmacokinetics.