Bioequivalent Study of Lactate Levofloxacin Dispersible Tablets in Healthy Volunteers

OBJECTIVE Compare the bioavailability of lactate levofloxacin dispersible tablets and levofloxacin tablets,and determine whether these two fomulations were bioequivalent.METHODS A single oral dose 200 mg of lactate levofloxacin dispersible tablets(test formulation) or levofloxacin tablets(reference formulation) were given to 20 male healthy volunteers in a randomized cross-over study.The concentrations of levofloxacin in serum were determined by HPLC.RESULTS The main pharmacokinetic parameters respectively in test or reference formulations were as follows:t1/2β(5.68±1.79) and(5.38±1.52)h;tmax(0.84±0.79) and(0.95±0.47)h;cmax(2.27±0.47) and(2.26±0.58)μg·mL-1;AUC0-t(14.90±2.14) and(15.62±2.49)μg·mL-1·h;AUC0-∞(15.17±2.34) and(15.87±2.67)μg·mL-1·h.The average relative bioavailability of AUC0-t and AUC0-∞ were(97.23±17.71)% and(97.43±17.76)%.The two one-sided t-test of AUC0-t,AUC0-∞ and cmax after logarithmic transformation showed that these two formulations were bioequivalent.The 90% confidence interval of cmax,AUC0-t and AUC0-∞ were 88.1%~117.3%,89.2%~102.5% and 89.3%~102.9%.No significance was found about tmax by rank sum test.No adverse events occurred through the whole trial.CONCLUSION These two formulations were bioequivalent according to the standards.