无人机片在健康参与者中与食物或没有食物一起服用的生物可用性
Gerald V Naccarelli1, David S McKindley2, Jason Rashkin2
1Department of Medicine, Heart and Vascular Institute, Penn State University College of Medicine, Hershey, PA, USA.
概括
与食物一起服用dronedarone可显著增加其生物可用性. 为了获得最佳的吸收,始终在完整的餐饮中摄入dronedarone.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物新陈代谢 药物新陈代谢
- 临床药理学 临床药理学
背景情况:
- 对于食物对无人机生物可用性的影响,人们的认识有限.
- 德罗内达龙是一种抗心律失常药物,用于维持心房动患者的正常鼻节律.
研究的目的:
- 为了评估食物对无人机的生物可用性的影响.
- 为无人机管理提供基于证据的建议.
主要方法:
- 在健康成年人中进行了两项第一阶段,开放式,随机的研究.
- 参与者在食 (脂肪含量不同) 和禁食条件下接受了单次口服剂量Dronedarone.
- 评估了dronedarone及其活性代谢物的药理动力学参数,包括Cmax和AUC.
主要成果:
- 在研究1中,与高脂肪餐一起服用无人机增加了Cmax的2.8倍和AUC的2.0倍.
- 在研究2中,与禁食相比,富含脂肪和低脂肪的食增加了Cmax分别为4.6倍和3.2倍,AUC分别为3.1倍和2.3倍.
- 没有任何不良事件归因于dronedarone.
结论:
- 食物显著提高了无人机的生物可用性.
- 为了最大限度地提高药物吸收和治疗效果,dronedarone应与饮食一起服用.
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