在双盲,安慰剂控制,交叉研究中的LSD基和酸盐的绝对口服生物可用性和生物等价性
Denis Arikci1,2,3, Friederike Holze1,2,3, Lorenz Mueller1,2,3
1Clinical Pharmacology and Toxicology, Department of Biomedicine, University Hospital Basel, Basel, Switzerland.
Lysergic acid diethylamide (LSD) 基和酸盐配方是生物等价的,并且显示出高的口服生物可用性. 不同的口服LSD形式具有相似的药理动力学和药理动力学,支持在研究中可互换使用.
科学领域:
- 心理药理学 心理药理学
- 神经科学是一个神经科学.
- 临床药理学 临床药理学
背景情况:
- Lysergic acid diethylamide (LSD) 正在针对精神和神经疾病进行调查.
- 使用了各种LSD配方 (基/酸盐,口服/静脉注射),但它们的药理学等价性尚不清楚.
- 在此之前,LSD的绝对口服生物利用率尚未确定.
研究的目的:
- 测试不同口服LSD基和酸盐配方的生物等价性.
- 为了确定LSD的绝对口服生物可用性.
- 为了比较不同配方的药理动力学和药理动力学特征.
主要方法:
- 一个随机的,双盲的,安慰剂控制的,五期的交叉研究.
- 涉及20名健康参与者接受口服LSD基 (乙醇溶液,药片),口服LSD酸盐 (水溶液),静脉注射LSD酸盐和安慰剂.
- 评估药物动力学参数,主观影响,自主反应和不良事件,长达24小时.
主要成果:
- 所有经过测试的口服LSD配方都是生物等价的,以乙醇基溶液作为参考.
- 液的绝对口服生物利用率约为80%,在各种配方中一致.
- 静脉注射的LSD诱导的主观效应更强,焦虑/恶心比口服形式更多.
结论:
- 液基和酸盐配方是生物等价的,并且具有高的,可比的口服生物利用性.
- 口服LSD配方表现出类似的药理动力学和药理动力学特性.
- 研究结果支持在临床研究中可互换使用口服LSD基和酸盐配方.
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