Pharmacokinetics study of Pazufloxacin Mesilate in multiple doses to chinese healthy volunteers

Objective:To investigate the pharmacokinetics of pazufloxacin mesilate in multiple doses to Chinese healthy volunteers.Methods:The protocol was designed according to GCP principle.10 volunteers were given multi-dose pazufloxacin mesilate and the plasma concentrations were determined by HPLC method and the pharmacokinetics parameters were calculated by DAS1.0 software.Results:The concentration-time curve fit two compartment model.The main pharmacokinetics parameters C0 of the 1st day and 5th day were (5.73±0.79)mg/L and (5.72±0.82)mg/L respectively,t1/2β were (2.01±0.27)h and (1.85±0.20)h respectively,AUC0-∞ of the 1st day was (13.50±2.47)mg·h·L-1 and AUC0-τ of the 5th day was (14.53±2.71) mg·h·L-1.Conclusion:Effective concentration in vivo could achieved after intravenous infusion of 300mg pazufloxacin mesilate twice a day for 5 days and no accumulation in human body was observed after 5 day administrations.The dosing schedule was recommended.