Research on the pharmacokinetics of single dose and multipledose of gemifloxacin in healthy Chinese male subjects

AIM： To investigate the pharmacokinetics and safety of gemifloxacin in healthy Chinese subjects and provide some theoretic bases for its reasonable application in clinic. METHODS： （1） 12 healthy Chinese male subjects were enrolled in this study with an open label, 3-period crossover oral single dosing pharmacokinetic study. The subjects sequentially took 3 doses of gemifloxacin （ 160, 320 and 480 mg） according to the randomization schedule. （2）20 subjects were chosen to participate in a randomized, double blind, multiple dosing pharmacokinetic study. The subjects were orally given 320 mg gemifloxacin or matching placebo once daily for 7 consecutive days. Clinical observation and laboratory test were performed during the study for the assessment of adverse events. The concentrations of gemifloxacin in serum and urine were determined by high performance liquid chromatogram （HPLC）. The pharmacokinetic parameters were analysed by 31797 analysis software. RESULTS： （1）The pharmacokinetic courses following single crossover oral dose of 160, 320 and 480 mg were all in accordance with the two-compartment model.[第一段]

Research on the pharmacokinetics of single dose and multipledose of gemifloxacin in healthy Chinese male subjects