Pharmacokinetic and safety profile of trans-resveratrol in a rising multiple-dose study in healthy volunteers

Pharmacokinetic and safety profile of trans-resveratrol in a rising multiple-dose study in healthy volunteers
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DOI:
10.1002/mnfr.200800177
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发表时间:
2009-05-01
影响因子:
5.2
通讯作者:
Soares-da-Silva, Patricio
Soares-da-Silva, Patricio
中科院分区:
农林科学2区
文献类型:
--
作者:
Almeida, Luis;Vaz-da-Silva, Manuel;Soares-da-Silva, Patricio

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这是一项双盲、随机、安慰剂对照研究,旨在研究反式白藜芦醇的药代动力学和安全性。在四组10名健康成年受试者(5名男性和5名女性)中,2名受试者被随机接受安慰剂治疗,8名受试者接受反式白藜芦醇25、50、100或150 mg,每天6次,共13次。反式白藜芦醇血药浓度在给药后0.8~1.5h达到峰值。第13剂反式白藜芦醇25、50、100和150 mg后,平均峰浓度(C-max)分别为3.89、7.39、23.1和63.8 ng/mL,平均血药浓度-时间曲线下面积(AUC(0-tau))分别为3.1、11.2、33.0和78.9 ng。H/m L。个体间变异性很高,变异系数为40%。单次给药后反式白藜芦醇半衰期为1~3h,重复给药后为2~5h。谷值(C-min)浓度为
This was a double-blind, randomised, placebo-controlled study to investigate the pharmacokinetics and safety of trans-resveratrol. In four groups of ten healthy adult subjects ( five males and five females), two subjects were randomized to receive placebo and eight subjects to receive trans-resveratrol 25, 50, 100 or 150 mg, six times/day, for thirteen doses. Peak plasma concentrations of trans-resveratrol were reached at 0.8-1.5 h postdose. Following the 13th dose of trans-resveratrol 25, 50, 100 and 150 mg, mean peak plasma concentration (C-max) was 3.89, 7.39, 23.1 and 63.8 ng/mL and mean area under the plasma concentration-time curve (AUC(0-tau)) was 3.1, 11.2, 33.0 and 78.9 ng . h/mL. Interindividual variability was high, with coefficients of variation >40%. Trans-resveratrol half-life was 1-3 h following single-doses and 2-5 h following repeated dosing. Trough (C-min) concentrations were