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首页> 外文期刊>Antimicrobial agents and chemotherapy. >Lack of effect of zafirlukast on the pharmacokinetics of azithromycin, clarithromycin, and 14-hydroxyclarithromycin in healthy volunteers.
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Lack of effect of zafirlukast on the pharmacokinetics of azithromycin, clarithromycin, and 14-hydroxyclarithromycin in healthy volunteers.

机译：扎鲁司特对健康志愿者的阿奇霉素，克拉霉素和14-羟基克拉霉素的药代动力学缺乏影响。

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摘要

This randomized, open-label, crossover study was conducted to investigate whether the coadministration of zafirlukast would affect the pharmacokinetics of azithromycin, clarithromycin, or 14-hydroxyclarithromycin (14-OHC). Twelve healthy subjects (six males and six females) received single 500-mg doses of azithromycin and clarithromycin with and without zafirlukast given to a steady-state concentration. Blood was collected prior to all macrolide doses and for 3 and 10 days after each clarithromycin and azithromycin dose, respectively. Serum was assayed for azithromycin, clarithromycin, and 14-OHC concentrations by validated high-performance liquid chromatography assay systems. Data analyses were done by noncompartmental and nonparametric methods. Analysis of the patients indicated that the addition of steady-state concentrations of zafirlukast did not significantly alter the pharmacokinetic parameters of or overall exposure (based on the area under the concentration-time curve) to azithromycin, clarithromycin, and 14-OHC. While zafirlukast is a known inhibitor of CYP3A4, it does not appear to exert a clinically or statistically significant pharmacokinetic effect on azithromycin, clarithromycin, or 14-OHC.
机译：进行了这项随机，开放标签，交叉研究，以研究扎鲁司特的共同给药是否会影响阿奇霉素，克拉霉素或14-羟基克拉霉素（14-OHC）的药代动力学。十二名健康受试者（六名男性和六名女性）接受了单次500毫克剂量的阿奇霉素和克拉霉素的治疗，有和没有扎鲁司特的稳态浓度。在所有大环内酯类药物剂量之前以及每次克拉霉素和阿奇霉素剂量之后分别为3天和10天收集血液。通过经过验证的高效液相色谱分析系统，测定血清中的阿奇霉素，克拉霉素和14-OHC浓度。数据分析通过非区室和非参数方法进行。对患者的分析表明，添加稳定浓度的扎鲁司特不会显着改变阿奇霉素，克拉霉素和14-OHC的药代动力学参数或总暴露量（基于浓度-时间曲线下的面积）。虽然扎鲁司特是一种已知的CYP3A4抑制剂，但似乎对阿奇霉素，克拉霉素或14-OHC没有发挥临床或统计学上显着的药代动力学作用。

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