Bioequivalence of levofloxacin hydrochloride tablets in Chinese healthy volunteers

OBJECTIVE To study the relative bioavailability and bioequivalence of Levofloxacin hydrochloride tablets in healthy volunteers.METHODS A single oral dose(200mg of tested and reference formulation) were given to 20 healthy volunteers in a randomised crossover study.The concentrations of Levofloxacin in plasma were determined by HPLC.The pharmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS program.RESULTS After a single dose,the pharmacokinetics parameters for Levofloxacin were as follows:Cmax were(2.88±0.61) mg·L-1 and(2.90±0.58) mg·L-1;Tmax were(1.17±0.62)h and(1.09±0.79)h;AUC(0-24) were(20.23±3.41) mg·h·L-1 and(20.11±3.61) mg·h·L-1;AUC(0-inf) were(21.97±3.84) mg·h·L-1 and(21.72±4.22) mg·h·L-1 for tested and reference formulations respectively.The 90% confidential interval of AUC(0-24),AUC(0-inf) and Cmax of tested formulation were 97.5%～104.2%,98.2%～104.9% and 92.5%～106.5%.CONCLUSION The relative bioavailability was(97.53±18.49) %;The results of the statistic analysis showed that the two formulations were bioequivalence.