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首页> 外文期刊>Frontiers in Neuropharmacology >Pharmacokinetics and Pharmacodynamics of Lisdexamfetamine Compared with D-Amphetamine in Healthy Subjects
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Pharmacokinetics and Pharmacodynamics of Lisdexamfetamine Compared with D-Amphetamine in Healthy Subjects

机译：Lisdexamfetamine与D-苯丙胺在健康受试者中的药代动力学和药效动力学

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Rationale Lisdexamfetamine is a prodrug of D-amphetamine used for the treatment of attention-deficit/hyperactivity disorder (ADHD). Lisdexamfetamine is thought to have a prolonged pharmacokinetic profile compared with oral D-amphetamine, possibly associated with lower drug liking and a lower risk of oral misuse. However, differences in the pharmacokinetics and pharmacodynamics of lisdexamfetamine and D-amphetamine have not been directly compared. Methods Equimolar doses of D-amphetamine (40mg) and lisdexamfetamine (100mg), and placebo were administered in 24 healthy subjects in a randomized, double-blind, placebo-controlled, cross-over study. Plasma concentrations of amphetamine, subjective effects, and vital signs were repeatedly assessed. The pharmacokinetic parameters were determined using compartmental modeling. Results The increase in plasma concentrations of amphetamine had a 0.6±0.6 h (mean±SD) longer lag time and reached peak levels 1.1±1.5 h later after lisdexamfetamine administration compared with D-amphetamine administration, but no differences in maximal concentrations or total exposure (AUC) were found between the two treatments. Consistent with the pharmacokinetics, the subjective and cardiovascular stimulant effects of lisdexamfetamine also occurred later compared with D-amphetamine. However, no differences in peak ratings of potentially abuse-related subjective drug effects (e.g., drug liking, drug high, stimulation, happy, well-being, and self-confidence) were observed after lisdexamfetamine administration compared with D-amphetamine administration. Lisdexamfetamine and D-amphetamine also produced similar peak increases in mean arterial blood pressure, heart rate, body temperature, pupil size, and adverse effects. Conclusions The pharmacokinetics and pharmacodynamics of lisdexamfetamine are similar to D-amphetamine administered 1h later. Lisdexamfetamine is likely associated with a similar risk of oral abuse as D-amphetamine.
机译：原理葡糖胺是D-苯异丙胺的前药，用于治疗注意力缺陷/多动症（ADHD）。与口服D-苯异丙胺相比，Leddexamfetamine被认为具有更长的药代动力学特征，可能与较低的药物喜欢性和较低的口服误用风险有关。但是，尚未直接比较赖氨苯丙胺和D-苯异丙胺的药代动力学和药效学差异。方法在随机，双盲，安慰剂对照，交叉研究中，对24位健康受试者给予等摩尔剂量的D-苯丙胺（40mg）和赖氨苯丙胺（100mg）以及安慰剂。反复评估了苯丙胺的血浆浓度，主观效果和生命体征。使用区室模型确定药代动力学参数。结果与D-苯丙胺相比，利培糖胺给药后苯丙胺的血浆浓度增加具有0.6±0.6 h（平均±SD）的较长滞后时间，并在1.1±1.5 h后达到峰值水平，但最大浓度或总暴露量无差异（AUC）被发现在两种治疗之间。与药代动力学一致，赖斯地非胺的主观和心血管刺激作用也较D-苯异丙胺晚。然而，与D-苯丙胺给药相比，利的氨苯丙胺给药后未观察到潜在的与滥用相关的主观药物作用（例如，药物喜欢，药物高度，刺激，快乐，幸福和自信心）的最高评分差异。 Lisdexamfetamine和D-amphetamine在平均动脉血压，心率，体温，瞳孔大小和副作用方面也产生了类似的峰值增加。结论赖氨苯丙胺的药代动力学和药效学与1小时后的D-苯异丙胺相似。 Lisdexamfetamine可能与D-amphetamine发生类似的口服滥用风险。

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