委内托克拉克斯 (Venetoclax) 的临床药理动力学在注射粉碎,研磨或整片药片后
Samaneh Alaei1, Yamin Wang1, Yueli Liu1
1AbbVie, Inc., Chicago, Illinois.
粉碎或磨碎venetoclax片对患有吞困难的患者来说,与整片药物具有生物等价性. 这种施用方法在血液性恶性瘤治疗中安全有效.
科学领域:
- 药理学和治疗学 药理学和治疗学
- 药物输送系统 药物输送系统
背景情况:
- 威尼托克拉克斯是一种用于血液性恶性瘤的BCL-2抑制剂.
- 对于患有吞困难的患者来说,存在管理方面的挑战.
研究的目的:
- 为了评估粉碎和粉碎的venetoclax片的生物利用性,与完整的片相比.
- 为了确定修改后的venetoclax配方是否保持治疗等效.
主要方法:
- 这是一项对15名健康女性进行的开放标签,随机,三向交叉研究.
- 在高脂肪早餐后,Venetoclax以粉碎,碎碎或完好无损的药片与水一起口服.
- 药物动力学采样时间为剂量后72小时.
主要成果:
- 粉碎和粉碎的venetoclax片显示与完整片的生物等价性 (AUCt和AUCinf).
- 对于修改后的配方,观察到Cmax的轻微,临床上无意义的下降.
- 在72小时的储存后,物理或物理化学性质没有变化.
结论:
- 粉碎或研磨维尼托克拉克斯 (venetoclax) 片对于有服用困难的患者来说是一个可行的替代方案.
- 经过修改的venetoclax配方可确保可比的整体药物暴露和疗效.
- 这便于为需要鼻胃管养或吞障碍的患者提供药物.
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