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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Influence of food intake on the pharmacokinetics of miglustat, an inhibitor of glucosylceramide synthase.
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Influence of food intake on the pharmacokinetics of miglustat, an inhibitor of glucosylceramide synthase.

机译：食物摄入量对葡糖神经酰胺合酶抑制剂米格司他的药代动力学的影响。

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摘要

The objective of this study was to investigate the effect of food on the pharmacokinetics of miglustat, an inhibitor of glucosylceramide synthase. Twenty-four healthy male (n = 9) and female (n = 15) subjects were treated in a randomized, 2-way crossover design with a single oral dose of 100 mg miglustat with or without food. Consumption of a standard high-fat breakfast within 30 minutes before administration of miglustat significantly reduced peak exposure but did not significantly affect the extent of systemic exposure to miglustat. The peak plasma concentration (C(max)) decreased by 36% on average following administration with food. Area under the plasma concentration-time curve (AUC(0-infinity)) showed a modest (14%) decrease with food, but the 90% confidence interval was within the acceptance limit of 80% to 125%. The median (min-max) time to C(max) (t(max)) was prolonged from 2.5 (1.0-4.0) hours in the fasted state to 4.5 (1.5-8.0) hours in the fed state, whereas the apparent terminal half-life was approximately 8 hours and not affected by food. In conclusion, the intake of food has an effect on some pharmacokinetic parameters such as C(max) and t(max) but does not affect the extent of exposure to miglustat. The observed effects of food intake on the pharmacokinetics of miglustat are not considered to be of clinical relevance.
机译：这项研究的目的是研究食物对葡糖神经酰胺合酶抑制剂米格司他的药代动力学的影响。对二十四名健康的男性（n = 9）和女性（n = 15）受试者进行了随机，两向交叉设计治疗，单次口服剂量为100 mg miglustat，含或不含食物。在服用米格司他之前30分钟内食用标准的高脂早餐可显着降低峰值暴露，但不会显着影响全身对米格司他的暴露程度。与食物一起服用后，血浆平均峰值浓度（C（max））平均降低了36％。血浆浓度-时间曲线下的面积（AUC（0-无穷大））随食物的摄入而略有下降（14％），但90％的置信区间在80％至125％的可接受范围内。到C（max）（t（max））的中位（min-max）时间从禁食状态下的2.5（1.0-4.0）小时延长到进食状态下的4.5（1.5-8.0）小时，而表观末梢半衰期约为8小时，不受食物的影响。总之，食物的摄入对某些药代动力学参数有影响，例如C（max）和t（max），但不影响暴露于米格司他的程度。食物摄入对米格司他的药代动力学的观察到的影响不被认为具有临床意义。

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