一种新的持续释放的普雷加巴林片在患有功能减弱的受试者中的药理动力学特性
Maria Park1,2, Suein Choi1,2, Sungpil Han1,2
1Department of Clinical Pharmacology and Therapeutics, The Catholic University of Korea Seoul St. Mary's Hospital, Seoul 06591, Korea.
Translational and clinical pharmacology
|January 10, 2024
概括
这项研究评估了功能减弱的患者中持续释放普雷加巴林 (YHD1119) 的药理动力学. 中度功能障碍显示了与正常功能相比的普雷加巴林暴露,支持每天服用一次剂量.
科学领域:
- 药理学 药理学是指药理学的学科.
- 腎臟病學 (nephrology) 是一種醫學專業.
- 药物开发 药物开发
背景情况:
- 持续释放 (SR) 甲巴林 (YHD1119) 允许每天服用一次.
- 功能障碍会改变药物的药理动力学,需要调整剂量.
- 了解YHD1119在功能障碍中的药理动力学对于安全有效的使用至关重要.
研究的目的:
- 在不同程度的功能患者中评估YHD1119片的药理动力学.
- 为了比较中度功能障碍患者和正常功能患者之间的药物暴露.
- 在功能受损人群中为YHD1119的剂量建议提供信息.
主要方法:
- 一项药理动力学研究,涉及具有60毫升/分钟/1.73米2 (A组) 和30-60毫升/分钟/1.73米2 (B组) 的肌素清除率高于60毫升/分钟/1.73米2的患者.
- 试验对象接受了YHD1119 75毫克 (Y75T) 和150毫克 (Y150T) 片 (A队列) 或Y75T (B队列).
- 进行了非分组和人群药理动力学分析.
主要成果:
- 与A组相比,中度功能障碍 (B组) 的患者对Y75T的最大度 (Cmax) 和度-时间曲线 (AUC) 下的面积 (AUC) 较高.
- 然而,在中度功能障碍患者中,Y75T对普雷加巴林的总暴露与近乎正常的功能患者中Y150T的总暴露相当.
- 模拟的稳定状态度支持了暴露的可比性.
结论:
- 在中度功能障碍的患者中,每天服用一次YHD1119的结果在正常功能患者中与较高剂量的普雷加巴林总暴露相比较.
- 这些发现支持在功能障碍患者中使用YHD1119的可能性.
- 可能需要进一步的研究来确定具体的剂量指南.
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