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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >The bioequivalence of telithromycin administered orally as crushed tablets versus tablets swallowed whole.
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The bioequivalence of telithromycin administered orally as crushed tablets versus tablets swallowed whole.

机译：泰利霉素经压片与口服吞服后的生物等效性。

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摘要

This open-label, randomized, crossover study was conducted to demonstrate bioequivalence for telithromycin administered as crushed or whole tablets. Single 800-mg telithromycin doses (2 x 400-mg tablets) were administered as crushed tablets mixed in 240 mL nutritional supplement drink followed by 120 mL water or as whole tablets swallowed with 240 mL water. Plasma telithromycin concentrations were measured by liquid chromatography/mass spectrometry; pharmacokinetic parameters were determined using noncompartmental methods. Average bioequivalence criteria were applied. Thirty-two subjects received telithromycin by both methods. The 90% confidence intervals for the geometric mean ratios of maximum plasma concentration and area under the plasma concentration-time curve to 24 hours were within the 0.80 to 1.25 range. Median t(max) was 3.00 hours for both treatments. Both methods of administration were well tolerated. Crushing telithromycin tablets and administering them with a nutritional supplement drink is bioequivalent to ingesting whole tablets and could be a viable method of administration for patients unable to swallow tablets whole.
机译：进行了这项开放标签，随机，交叉研究，以证明以压片或整片形式给药的泰利霉素的生物等效性。将800毫克的泰利霉素单次剂量（2 x 400毫克的片剂）以压碎的片剂的形式与240 mL营养补充剂饮料混合，然后以120 mL的水或完整的片剂吞入240 mL的水的形式给药。通过液相色谱/质谱法测定血浆telithromycin浓度;使用非房室方法确定药代动力学参数。应用平均生物等效性标准。 32名受试者通过两种方法均接受了泰利霉素。血浆浓度-时间曲线下至24小时的最大血浆浓度和面积的几何平均比的90％置信区间在0.80至1.25范围内。两种处理的中位t（max）为3.00小时。两种给药方法均耐受良好。压碎telithromycin片剂并与营养补品饮料一起服用与摄入整片具有生物等效性，并且对于无法完全吞服片剂的患者可能是一种可行的给药方法。

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