延长释放洛拉泽的表征:在第一阶段临床研究中的药理动力学结果
Sanjay J Mathew1, Shedly Jean-Lys2, Rupinder Phull2
1From the Menninger Department of Psychiatry and Behavioral Sciences at Baylor College of Medicine, Houston, TX.
延长释放 (ER) 洛拉泽提供了与即时释放 (IR) 洛拉泽具有生物等效的药理学特征,减少了用于缓解焦虑的血水平波动. 在第一阶段试验中,这种新的ER配方在健康成年人中耐受良好.
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
- 药物开发 药物开发
背景情况:
- 洛拉泽即时释放 (IR) 用于短期缓解焦虑.
- 红外线洛拉泽的血水平波动可能是令人担忧的.
- 延长释放 (ER) 洛拉泽帕姆是为了提供更稳定的血度而开发的.
研究的目的:
- 描述每天一次ER lorazepam的药理动力学和安全性.
- 为了在健康成年人中比较ER lorazepam与IR lorazepam.
- 评估食物和施用方法对ER的影响. lorazepam.
主要方法:
- 第一个阶段,随机,开放标签,多期交叉研究.
- 对比ER洛拉泽巴姆 (3毫克每天一次) 与IR洛拉泽巴姆 (1毫克三次).
- 评估ER lorazepam与/或没有食物和完整的/喷的管理.
主要成果:
- 每天一次的ER lorazepam表现出与IR lorazepam TID的稳定状态生物等价性.
- 与IR (1小时) 相比,ER lorazepam显示出延迟的峰值度 (11小时).
- 埃尔埃洛拉泽帕姆是生物等价的,无论食物摄入或施用方法 (完好无损/喷).
结论:
- 与TID IR lorazepam相比,每天一次的ER lorazepam是生物等价的,并且耐受性很好.
- ER lorazepam为焦虑管理提供了一个潜在的改进剂量方案.
- 这些发现支持ER lorazepam作为IR lorazepam的替代品.
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