Bioequivalence of fleroxacin tablets in healthy voluntees

OBJECTIVE To study the relative bioavailability of fleroxacin tablets in healthy volunteers and to evaluate the bioequivalence between the reference and the test preparations.METHODS A single oral dose of 400 mg fleroxacin tablets of reference or test preparations was given to each volunteer according to an open randomized cross-over study.The concentrations of fleroxacin in plasma were determined by HPLC.The pharmacokinetic parameters were calculated and the bioequivalence were evaluated by DAS 1.0 program.RESULTS After a single oral admistration of 400 mg test or reference tablets,the main pharmacokinetic parameters were as follows:AUC_(0→t) were((76 245.4)±(9 991.0))μg·h·L~(-1) and((78 295.9)±(10 566.8)) μg·h·L~(-1) respectively,AUC_(0→)∞ were((79 792.1)±(10 599.3))μg·h·L~(-1) and((81 037.9)±(10 807.6)) μg·h·L~(-1) respectively;C_(max) were((5 218.8)±(1 493.8))μg·L~(-1) and((4 983.9)±(910.7))μg·L~(-1) respectively;t_(max) were((1.8)±(1.0)) h and((2.0)±(1.0))h respectively.Analysis of variance and t-test for AUC_(0→t)、AUC_(0→)∞ and C_(max),rand sum test for t_(max) showed that there was no significant difference between the two preparations.CONCLUSION The two preparations are bioequivalent,the relative bioavailability of the test tablets is((98.4)±(13.4))% calculated according to AUC_(0→t).