Wong Y N, Wang L, Hartman L, Simcoe D, Chen Y, Laughton W, Eldon R, Markland C, Grebow P
Cephalon, Inc., West Chester, Pennsylvania, USA.
J Clin Pharmacol. 1998 Oct;38(10):971-8. doi: 10.1002/j.1552-4604.1998.tb04395.x.
An open-label, randomized, crossover study was performed in healthy male volunteers to evaluate the potential pharmacokinetic and pharmacodynamic interactions and tolerability of single oral doses of modafinil (200 mg) and dextroamphetamine (10 mg). Blood samples were collected for determination of plasma levels of modafinil, the acid and sulfone metabolites of modafinil, and dextroamphetamine at intervals through 48 hours after administration for each treatment. Vital signs (blood pressure and pulse rate) were measured through 48 hours, and electrocardiograms were measured through 24 hours after administration. Pharmacokinetic parameters were determined using noncompartmental methods. The data collected in this study of 24 healthy volunteers suggest that concomitant administration of single oral doses of modafinil and dextroamphetamine has no clinically significant effects on the pharmacokinetic profile of either agent. Although there was a slightly greater incidence of adverse events when modafinil and dextroamphetamine were administered together, the concomitant administration of the two drugs was well tolerated.
在健康男性志愿者中进行了一项开放标签、随机、交叉研究，以评估单次口服莫达非尼（200毫克）和右旋苯丙胺（10毫克）的潜在药代动力学和药效学相互作用及耐受性。在每次治疗给药后的48小时内，间隔采集血样，用于测定莫达非尼、其酸代谢物和砜代谢物以及右旋苯丙胺的血浆水平。在48小时内测量生命体征（血压和脉搏率），并在给药后24小时内测量心电图。使用非房室方法确定药代动力学参数。这项针对24名健康志愿者的研究收集的数据表明，单次口服莫达非尼和右旋苯丙胺对任何一种药物的药代动力学特征均无临床显著影响。尽管莫达非尼和右旋苯丙胺合用时不良事件的发生率略高，但两种药物的合用耐受性良好。
