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Abstract：Background and Objective：T
Abstract：Background and Objective：Trans-resveratrol is a polyphenol, which is found in red wine and has cancer chemo-preventive properties and disease-preventive properties. The pharmacokinetics of trans-resveratrol have been investigated in single-dose studies and in studies with relatively low dosages. The present study aimed to investigate the steady-state pharmacokinetics and tolerability of trans-resveratrol 2000 mg twice daily with food, quercetin and alcohol (ethanol). Methods：This was a two-period, open-label, single-arm, within-subject control study in eight healthy subjects. The steady-state 12-hour pharmacokinetics of trans-resveratrol 2000 mg twice daily were studied with a standard breakfast, a high-fat breakfast, quercetin 500 mg twice daily and 5% alcohol 100 mL. Trans-resveratrol plasma concentrations were determined using liquid chromatography with tandem mass spectrometry. Results：The mean (SD) area under the plasma concentration-time curve from 0 to 12 hours (AUC12) and maximum plasma concentration (Cmax) of trans-resveratrol were 3558 (2195) ng •h/mL and 1274 (790) ng/mL, respectively, after the standard breakfast. The high-fat breakfast significantly decreased the AUC12 and Cmax by 45% and 46%, respectively, when compared with the standard breakfast. Quercetin 500 mg twice daily or 5% alcohol 100mL did not influence trans-resveratrol pharmacokinetics. Diarrhoea was reported in six of the eight subjects. Significant but not clinically relevant changes from baseline were observed in serum potassium and total bilirubin levels. Conclusion：Trans-resveratrol 2000 mg twice daily resulted in adequate exposure and was well tolerated by healthy subjects, although diarrhoea was frequently observed. In order to maximize trans-resveratrol exposure, it should be taken with a standard breakfast and not with a high-fat meal. Furthermore, combined intake with quercetin or alcohol did not influence trans-resveratrol exposure.
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摘要：背景与目的：白藜芦醇是一种多酚，它在红葡萄酒中发现，有癌症化疗预防性质和疾病预防性质。白藜芦醇的药代动力学单剂量研究，并与相对较低剂量的研究进行了研究。针对本研究每天的食物，槲皮素和酒精（乙醇）两次调查稳态药代动力学和白藜芦醇2000毫克的耐受性。方法：这是一个两期，开放标签，单臂，内对象控制在八个健康受试者的研究。的反式白藜芦醇2000毫克的稳态12小时的药代动力学，每天两次进行了研究具有标准早餐，高脂肪早餐，槲皮素500 mg，每天两次和5％的醇100毫升。用液相色谱串联质谱法测定的反式白藜芦醇的血浆浓度。结果：从0到12小时（AUC12）和最大血浆浓度的反式白藜芦醇的（C max）的血浆浓度 - 时间曲线下的平均（SD）区域进行3558（2195）纳克•H / mL和1274（790）毫微克/毫升，分别，标准早餐后。高脂肪早餐时与标准早餐相比，分别为45％和46％，显著降低AUC12和Cmax。槲皮素500毫克，每天两次或5％酒精100毫升并没有影响白藜芦醇的药代动力学。腹泻报道，在8名受试者中的六个。显著但不是血钾和总胆红素水平，观察从基线临床相关的变化。结论：白藜芦醇2000毫克，每天两次造成充分暴露和健康受试者的耐受性良好，虽然腹泻经常被观察到。为了最大限度地提高白藜芦醇曝光，应该采取一个标准的早餐，而不是用高脂肪食物。此外，结合槲皮素或酒精并没有影响白藜芦醇曝光量。
正在翻译中..
Abstract：Background and Objective：Trans-resveratrol is a polyphenol, which is found in red wine and has cancer chemo-preventive properties and disease-preventive properties. The pharmacokinetics of trans-resveratrol have been investigated in single-dose studies and in studies with relatively low dosages. The present study aimed to investigate the steady-state pharmacokinetics and tolerability of trans-resveratrol 2000 mg twice daily with food, quercetin and alcohol (ethanol). Methods：This was a two-period, open-label, single-arm, within-subject control study in eight healthy subjects. The steady-state 12-hour pharmacokinetics of trans-resveratrol 2000 mg twice daily were studied with a standard breakfast, a high-fat breakfast, quercetin 500 mg twice daily and 5% alcohol 100 mL. Trans-resveratrol plasma concentrations were determined using liquid chromatography with tandem mass spectrometry. Results：The mean (SD) area under the plasma concentration-time curve from 0 to 12 hours (AUC12) and maximum plasma concentration (Cmax) of trans-resveratrol were 3558 (2195) ng •h/mL and 1274 (790) ng/mL, respectively, after the standard breakfast. The high-fat breakfast significantly decreased the AUC12 and Cmax by 45% and 46%, respectively, when compared with the standard breakfast. Quercetin 500 mg twice daily or 5% alcohol 100mL did not influence trans-resveratrol pharmacokinetics. Diarrhoea was reported in six of the eight subjects. Significant but not clinically relevant changes from baseline were observed in serum potassium and total bilirubin levels. Conclusion：Trans-resveratrol 2000 mg twice daily resulted in adequate exposure and was well tolerated by healthy subjects, although diarrhoea was frequently observed. In order to maximize trans-resveratrol exposure, it should be taken with a standard breakfast and not with a high-fat meal. Furthermore, combined intake with quercetin or alcohol did not influence trans-resveratrol exposure.
正在翻译中..
摘要：背景与目的：反式白藜芦醇是一种多酚类物质，存在于红酒中，具有抗癌、防病的作用。反式白藜芦醇的药代动力学已在单剂量研究和相对低剂量研究中进行了研究。本研究旨在研究反式白藜芦醇（2000毫克，每日两次）与食物、槲皮素和酒精（乙醇）的稳态药代动力学和耐受性。方法：对8名健康受试者进行两阶段、开放标签、单臂、受试者内对照研究。以标准早餐、高脂早餐、槲皮素500mg、槲皮素500mg、5%乙醇100ml为对照，研究了反式白藜芦醇2000mg、每日2次的稳态12小时药代动力学。结果：标准早餐后，反式白藜芦醇血药浓度-时间曲线下0～12h（AUC12）和最大血药浓度（Cmax）的平均值（SD）分别为3558（2195）ng•h/mL和1274（790）ng/mL。高脂肪早餐与标准早餐相比，AUC12和Cmax分别降低了45%和46%。槲皮素500mg，每日两次，或5%乙醇100mL，均不影响反式白藜芦醇的药代动力学。8名受试者中有6人报告腹泻。血清钾和总胆红素水平较基线水平有显著但无临床相关性变化。结论：反式白藜芦醇2000毫克，每日两次，可使健康人充分接触，且耐受性良好，但经常出现腹泻。为了最大限度地暴露反式白藜芦醇，应与标准早餐一起服用，而不是与高脂肪膳食一起服用。此外，与槲皮素或酒精联合摄入不影响反式白藜芦醇暴露。
正在翻译中..
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