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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Food does not affect the pharmacokinetics of tesaglitazar, a novel dual peroxisome proliferator-activated receptor alpha/gamma agonist.
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Food does not affect the pharmacokinetics of tesaglitazar, a novel dual peroxisome proliferator-activated receptor alpha/gamma agonist.

机译：食物不会影响tesaglitazar（一种新型的双重过氧化物酶体增殖物激活的受体α/γ激动剂）的药代动力学。

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摘要

Tesaglitazar is a dual peroxisome proliferator-activated receptor (PPAR) alpha/gamma agonist in development to treat lipid and glucose abnormalities associated with type 2 diabetes. This study evaluated the effects of food on tesaglitazar pharmacokinetics. In an open, randomized, 2-way crossover study, 20 healthy men received tesaglitazar 1 mg during fasting and after a high-fat, high-calorie breakfast. Blood samples were taken to assess pharmacokinetic variables. Systemic exposure to tesaglitazar was unaffected by food intake. Estimated ratios were 0.99 (90% confidence interval [CI], 0.94-1.04) for fed/fasted area under plasma concentration-time curve and 0.82 (90% CI, 0.78-0.86) for fed/fasted maximum plasma concentration (C(max)). Mean C(max) was approximately 18% lower (0.41 [95% CI, 0.38-0.43] versus 0.50 [95% CI, 0.47-0.53] mumol/L), and median time to C(max) was increased (2.00 vs 0.75 h) in fed versus fasted state. The median difference of t(max) was 1.25 h (P = .0001, signed-rank test). Tesaglitazar was well tolerated. Tesaglitazar pharmacokinetics is unaffected by food intake, allowing once-daily administration of tesaglitazar with or without food in clinical practice.
机译：Tesaglitazar是一种过氧化物酶体增殖物激活受体（PPAR）α/γ激动剂，正在开发中，用于治疗与2型糖尿病相关的脂质和葡萄糖异常。这项研究评估了食物对替格列塔扎药代动力学的影响。在一项开放，随机，二分法的交叉研究中，有20名健康男性在禁食期间和高脂，高热量早餐后接受1 mg tesaglitazar。采集血样以评估药代动力学变量。全身摄入tesaglitazar不受食物摄入的影响。血浆浓度-时间曲线下进食/禁食区域的估计比例为0.99（90％置信区间[CI]，0.94-1.04），进食/禁食的最大血浆浓度（C（max）为0.82（90％CI，0.78-0.86） ））。平均C（max）降低约18％（0.41 [95％CI，0.38-0.43] vs 0.50 [95％CI，0.47-0.53] mumol / L），达到C（max）的中位数时间增加（2.00 vs 0.75小时）处于进食与禁食状态。 t（max）的中位数差异为1.25 h（P = .0001，有序秩检验）。 Tesaglitazar的耐受性良好。 Tesaglitazar的药代动力学不受食物摄入量的影响，因此在临床实践中允许每天一次与食物一起或不与食物一起服用tesaglitazar。

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