在健康成年人中,通过各种替代性口服给药方法,费德拉提尼布的相对生物可用性
Yizhe Chen1, David Wyatt2, Massimo Attanasio3
1Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA. Yizhe.Chen@bms.com.
Cancer chemotherapy and pharmacology
|November 13, 2023
概括
通过囊分散或鼻胃管给药的费德拉提尼布显示出与骨髓纤维化患者完整囊相似的生物可用性. 替代剂量方法是安全和可口的,有助于患有吞困难的患者.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物运输 药物运输 药物运输
- 在瘤学瘤学.
背景情况:
- 费德拉提尼布是一种口服的Janus激酶2抑制剂,用于治疗骨髓纤维化.
- 一些患者在服用口服囊时遇到困难.
- 需要使用替代剂量方法来改善患者的服药.
研究的目的:
- 评估替代性fedratinib口服方式的生物可用性.
- 评估安全性,耐受性,味道和可口性.
- 比较完整的囊,分散的内容,鼻胃管和分剂量.
主要方法:
- 随机,第一阶段,开放标签,两部分交叉研究.
- 健康的成年人通过不同的口服方法接受费德拉提尼布400毫克.
- 进行了药理动力学分析 (AUC0-t) 和安全性评估.
主要成果:
- 完整的囊和分散的内容的生物利用性是相似的.
- 随着鼻胃和分割剂量观察到略有减少的暴露.
- 没有发现新的安全信号;分散形式的味道和可口性是可以接受的.
结论:
- 对费德拉提尼布的替代口服施用方法在暴露中没有临床显著的差异.
- 研究结果支持在患有吞问题的患者中使用分散或替代的费德拉提尼布剂量.
- 改进的药物管理可能会提高骨髓纤维化患者的治疗坚持.
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