药物开发 药物开发
Denis G Kay1, Kurt P Grady1, Andrew J Wahlert1
1Alpha Cognition Inc, Vancouver, BC, Canada.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 26, 2025
概括
在阿尔茨海默氏症痴呆症治疗中,ZUNVEYL (甲胺) 证明了剂量相称性. 这种延迟释放前药物可以减少与乙胆酶抑制剂常见的胃肠道副作用.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床药房 临床药房
- 神经科学是一个神经科学.
背景情况:
- 津维尔 (甲胺) 是FDA批准的治疗轻度至中度阿尔茨海默氏症痴呆症的甲胺原药.
- 它使用延迟释放 (DR) 配方,可能减轻与乙胆酶抑制剂相关的胃肠道副作用.
- 505 (b) (2) 途径的批准利用了FDA对加兰他胺酸产品的现有发现.
研究的目的:
- 为了评估ZUNVEYL DR片在5-15毫克的剂量范围内的剂量比例.
- 在健康成年人中评估ZUNVEYL DR药片的药理动力学特征.
主要方法:
- 一个开放的,随机的,三臂,单剂量并行研究在42名健康成年人中进行,在禁食条件下进行.
- 参与者接受了ZUNVEYL DR片剂的单剂量,分别为5mg,10mg或15mg.
- 分析了药物动力学参数,以确定剂量相称性.
主要成果:
- 这项研究分析了来自ZUNVEYL的兰胺的血度.
- 在15毫克的剂量下报告了一次胃肠道不良事件,这表明与相应剂量的加兰胺酸相比,其发生率可能更低.
- 药物动力学概况表明ZUNVEYL在研究范围内的剂量相称性.
结论:
- ZUNVEYL的耐受性很好,没有观察到任何严重的不良事件.
- 统计分析证实了Cmax,AUC0-t和AUC0-∞从5毫克到15毫克的剂量比例.
- 一个5毫克的ZUNVEYL DR药片与一个4毫克的胺酸立即释放药片具有生物等价性.
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