Abstract: AIM: To evaluate the bioequivalence of tosufloxacin test tablets and reference tablets in healthy Chinese volunteers.METHODS: Eighteen healthy male Chinese volunteers were enrolled and orally administrated 0.3 g tosufloxacin test tablets or reference tablets,the concentration of tosufloxacin in plasma were determined by HPLC. The pharmacokinetic parameters were calculated with the aid of DAS 2.0 pharmacokinetics software. The bioequivalence of the test and reference tablets were calculated by analysis of variance, two one sided t-test.RESULTS:The pharmacokinetic parameters of tosufloxacin test tablets and reference tablets were as following:t_1/2 (5.17±1.96) and (5.13±2.10) h;t_max (0.89±0.19) and (0.86±0.20) h;C_max (0.53±0.09) and (0.51±0.09) μg/mL;AUC_{0-24 h} (1.75±0.67) and (1.76±0.66) μg·h·mL^-1;AUC_0→∞ (1.98±0.74) and (1.98±0.76) μg·h·mL^-1,respectively. The relative bioavailability of two formulations was (101.1±15.6) %.CONCLUSION: The results of statistical analysis demonstrated that the two preparations were bioequivalent.

Key words: Tosufloxacin tosylate dispersible tablet, Pharmacokinetics, Bioavailability