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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Tolerability of fosaprepitant and bioequivalency to aprepitant in healthy subjects.
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Tolerability of fosaprepitant and bioequivalency to aprepitant in healthy subjects.

机译：在健康受试者中，福沙瑞汀的耐受性和对阿瑞吡汀的生物等效性。

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摘要

Fosaprepitant is an intravenous formulation of aprepitant, an oral NK1 antagonist used to prevent chemotherapy-induced nausea and vomiting. This randomized study was designed to evaluate fosaprepitant in polysorbate 80 vehicle for tolerability and bioequivalency to aprepitant. Tolerability was assessed by physical and laboratory examinations and adverse events. Plasma collected for 72 hours was assayed for aprepitant and fosaprepitant. Analysis of variance models were applied to natural log-transformed aprepitant area under the curve (AUC) data. Fosaprepitant up to 150 mg (1 mg/mL) was generally well tolerated. Fosaprepitant 115 mg was AUC bioequivalent to aprepitant 125 mg; the 90% confidence interval for the geometric mean ratio of aprepitant AUC for fosaprepitant 115 mg/aprepitant 125 mg fell within prespecified equivalence bounds of 0.80 to 1.25.
机译：Fosaprepitant是静脉注射的aprepitant，一种口服NK1拮抗剂，用于预防化疗引起的恶心和呕吐。这项随机研究旨在评估聚山梨酯80载体中的fosaprepitant的耐受性和对areppitant的生物等效性。通过身体和实验室检查以及不良事件评估耐受性。测定收集72小时的血浆中的阿瑞品和福沙瑞品。将方差模型分析应用于曲线（AUC）数据下的自然对数转换的阿雷峰区域。通常对高达150 mg（1 mg / mL）的Fosaprepitant耐受良好。 115 mg Fosaprepitant相当于125 mg AUC。对于115 mg甲环丙戊酸/ 125 mg甲环丙戊酸的apitpitant AUC几何平均比率，其90％置信区间落在预设的等价范围0.80至1.25之间。

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