Study on pharmacokinetics and bioequivalence of Gatifloxacin tablets in Chinese healthy volunteers

Objective:To study pharmacokinetics and bioequivalence of domestic and imported Gatifloxacin tablets in Chinese healthy volunteers.Methods:A single oral dose 400mg of domestic and imported Gatifloxacin tablets were given to 24 healthy volunteers in a randomized cross-over study.The concentrations of Gatifloxacin in human plasma were determined by HPLC and the pharmacokinetic parameters were calculated by DAS software.Results:The concentration-time curve of Gatifloxacin in plasma fit two compartment model after an oral single dose 400mg.The main pharmacokinetic parameters of domestic and imported tablet were as follows:Tmax were(0.99±0.41)h and(1.11±0.60)h,Cmax were(4.11±0.76)μg/mL and(3.89±0.54)μg/mL,t1/2β were(2.16±0.62)h and(2.31±0.50)h,AUC0-36h were(29.81±5.70)μg·mL-1·h and(30.77±4.40)μg·mL-1·h,AUC0-∞ were(30.97±6.01)μg·mL-1·h and(31.85±4.58)μg·mL-1·h respectively.The relative bioavailability of Gatifloxacin was(97.63±19.15)%.Conclusion:The domestic and imported Gatifloxacin tablets were bioequivalent.