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Pharmacokinetics of antofloxacin hydrochloride, a novel fluoroquinolone, after single-dose intravenous administration in healthy Chinese male volunteers



Pharmacokinetics of antofloxacin hydrochloride, a novel fluoroquinolone, after single-dose intravenous administration in healthy Chinese male volunteers



Xenobiotica; the Fate of Foreign Compounds in Biological Systems 40(5): 344-349



The purpose of the study was to evaluate the pharmacokinetic characteristics of a single, intravenous dose of antofloxacin hydrochloride in healthy Chinese male volunteers. Twelve subjects were randomly assigned to groups that received a single, intravenous dose of 200, 300, or 400 mg antofloxacin hydrochloride in a three-way crossover design study. The serum and urine concentrations of antofloxacin were then assayed with high-performance liquid chromatography (HPLC). Major pharmacokinetic parameters and urine excretion were obtained up to 96 h after administration. All three dosages were well tolerated. No clinically adverse reactions or abnormal laboratory results were detected. After single-dose intravenous administration, antofloxacin hydrochloride exhibited linear pharmacokinetic characteristics with increasing dosages. The C(max) for groups treated with 200, 300, or 400 mg dosages were 2.05 +/- 0.38, 3.01 +/- 0.60, and 3.80 +/- 0.78 mg l(-1), respectively; the areas under the curve from zero to infinity (AUC(0-infinity)) were 25.14 +/- 2.95, 37.63 +/- 5.42, and 53.87 +/- 9.48 mg l(-1).h, respectively. The t(1/2)(beta) was around 20 h; and the urinary excretion was measured as being from 58% to 60% within 96 h. Based on these results, 300 mg of antofloxacin hydrochloride administered once daily is the dose suggested for further investigation in multiple-dose administration studies.

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Accession: 054958613

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PMID: 20230254

DOI: 10.3109/00498251003649798


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