在健康的中国受试者中对阿齐尔萨坦的生物等价性研究
Xiaobei Liu1, Xiangrong Dai2, Xiaohui Yu2
1Anqing Medical College, Anqing, China.
Clinical pharmacology in drug development
|October 18, 2024
概括
这项研究发现,阿齐尔沙坦片在健康的中国成年人中具有生物等价性和安全性,无论是否与食物一起服用或不服用. 这证实了不同条件下的药物性能一致.
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
- 生物等价性研究 生物等价性研究
背景情况:
- 阿齐尔沙坦是一种血管激素II受体阻断剂,对治疗高血压至关重要.
- 它在高风险患者中为心血管提供了显著的益处,包括心力衰竭和糖尿病病患者.
- 了解其在不同生理条件下的吸收对于有效的治疗用途至关重要.
研究的目的:
- 在健康的中国志愿者中,评估阿齐尔沙坦片在禁食和食后状态之间的生物等价性.
- 在这些条件下评估阿齐尔沙坦的安全性.
主要方法:
- 一个随机的,开放的,单剂量,双交叉临床试验,涉及60名健康的中国人.
- 血亚齐尔沙坦度是在20毫克的测试或参考制剂后使用液体染色学-并联质谱法测量后.
- 使用专门的软件 (WinNonlin 8.2和SAS 9.4) 分析了药理动力学参数和生物等价性.
主要成果:
- 对于关键的药理动力学参数 (Cmax,AUC0-t,AUC0-∞) 的几何平均比率和90%的置信区间都在80%-125%的生物等效范围内.
- 在禁食 (30%) 和食后 (33.3%) 组中,不良事件发生率相似.
- 没有报告严重的不良事件或意想不到的药物反应.
结论:
- 阿齐尔沙坦片 (试验和参考制剂) 在健康的中国受试者中在禁食和食后条件下都具有生物等价性.
- 这种药物在这个人群中表现出良好的安全性,无论食物摄入量如何.
- 这些发现支持阿齐尔沙坦的治疗效果一致,不管是吃饭的时间.
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