健康男性志愿者多次给药后氧氟沙星口服与静脉给药的生物等效性。
Bioequivalence of oral and intravenous ofloxacin after multiple-dose administration to healthy male volunteers.
作者信息
Flor S C, Rogge M C, Chow A T
机构信息
R. W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey 08869.
出版信息
Antimicrob Agents Chemother. 1993 Jul;37(7):1468-72. doi: 10.1128/AAC.37.7.1468.
Abstract
The bioequivalence of oral and intravenous ofloxacin was investigated after the administration of multiple doses of 400 mg every 12 h to 20 healthy male volunteers in a randomized, crossover, open-label study. Ofloxacin concentrations in plasma were evaluated after 4 days of oral or intravenous (1-h infusion) dosing with a 3-day wash-out period between regimens. As expected, delivery to the systemic circulation took slightly longer after the oral dosing (time to maximum concentration of drug in serum of 1.7 h) relative to the 1-h intravenous infusion, but the systemic availabilities of ofloxacin by the two routes of administration were equivalent (area under the concentration-time curve from 0 to 12 h ratio of 95%). Since previous studies have not demonstrated any change in the bioavailability of ofloxacin in infectious disease patients, this study supports the interchangeability of these dosing regimens.
摘要
在一项随机、交叉、开放标签研究中，对20名健康男性志愿者每12小时多次给予400毫克氧氟沙星后，研究了口服和静脉注射氧氟沙星的生物等效性。在口服或静脉注射（1小时输注）给药4天后，评估血浆中的氧氟沙星浓度，两种给药方案之间有3天的洗脱期。正如预期的那样，与1小时静脉输注相比，口服给药后药物进入体循环的时间稍长（血清中药物达到最大浓度的时间为1.7小时），但两种给药途径的氧氟沙星全身可用性相当（0至12小时浓度-时间曲线下面积比为95%）。由于先前的研究未证明感染性疾病患者中氧氟沙星的生物利用度有任何变化，本研究支持这些给药方案的互换性。
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本文引用的文献
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需注意，你提供的原文“of ofloxacin”表述有误，应该是“ofloxacin”，我按照正确的“ofloxacin”（氧氟沙星）进行了翻译。
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