Pharmacokinetics and Bioequiavailability of Levofloxacin Tablets in Healthy Volunteers

OBJECTIVE: To study the pharmacokinetics and bioequiavailability of 2 kinds of levofloxacin tablets in healthy volunteers.METHODS: A single dose of test and reference tablets of levofloxacin were given to 20 healthy male volunteers in a randomized cross-over study.Plasma level of levofloxacin were detected by HPLC and the pharmacokinetic parameters and bioequiavailability of 2 kinds of levofloxacin tablets were computed.RESULTS: The main pharmacokinetic parameters of the test and the reference preparations were as follows: Cmax were(6.54±1.39) mg·L-1 and(6.31±1.21) mg·L-1;tmax were(1.04±0.39)h and(1.04±0.40)h;t1/2 were(7.77±0.84)h and(7.98±1.30)h;AUC0～24 were(50.66±5.84) mg·h·L-1 and(50.94±4.82) mg·h·L-1;AUC0～∞ were(57.55±6.75) mg·h·L-1 and(58.42±6.40) mg·h·L-1,respectively.Estimated by AUC0～24,the relative bioavailability of the test preparation was(100.20±14.23)%.CONCLUSION: The result of statistical analysis showed that test and the reference tablets of levofloxacin were bioequivalent.