OBJECTIVE To investigate the pharmacokinetics of prulifloxacin tablets in Chinese healthy volunteers after a single dose and multiple doses. METHODS Using crossover design, a single dose of 200, 400, 600 mg of prulifloxacin tablets and multiple doses of 400 mg were given to each of 10 healthy volunteers. The concentrations of NM394, an active metabolite of prulifloxacin in plasma, were determined by HPLC. The pharmacokinetic parameters were calculated by DAS2.0 programme. RESULTS The elimination half life and the mean residence time of single dose were obtained and the means of ρmax, AUC0-t and AUC0-∞ had a good linear relationship with the dose. The obtained pharmacokinetic parameters of prulifloxacin tablets in multiple doses of 400 mg group were as follows: AUC (15.69±3.20) mg·h·L-1, AUC (16.38±3.34) mg·h·L-1, t1/2α (1.28±0.58) h, t1/2β (7.95±3.28) h. CONCLUSION The differences of the main pharmacokinetic parameters of t1/2, V/F and CL/F between each group were not significant and drug accumulation was not found. There was no drug accumulation and prulifloxacin showed good safety.
Key words
prulifloxacin /
NM394 /
pharmacokinrtic /
HPLC
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References
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（ 收稿日期 ： 2009-02-19 ）
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