埃托米达的药理动力学和药理动力学评估研究:一个随机的,开放的,在健康的中国受试者中进行了为期2个周期的交叉研究
Ying Ding1, Nan-Nan Chu1, Rui Wang2
1Drug Clinical Trial Institution, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, 214023, Jiangsu, China.
这项研究发现,在健康的中国受试者中,两种埃托米达脂肪乳液表现出类似的药理动力学和药理动力学特性. 两种配方都被发现是安全的,耐受性良好,支持它们的生物等价性.
科学领域:
- 药理学和制药科学 药理学和制药科学
- 麻醉学 麻醉学
- 药物开发和生物等价性研究研究.
背景情况:
- 埃托米达是对GABA受体起作用的镇静催眠药,对于重症患者的麻醉诱导,维持和长期镇静至关重要.
- 了解不同埃托米达制剂的药理动力学和药理动力学特征对于确保治疗等价性和患者安全至关重要.
研究的目的:
- 为了评估和比较两个埃托米达脂肪乳液配方的药理动力学 (PK) 和药理动力学 (PD) 特性.
- 对健康的中国人进行静脉注射后的埃托米达脂肪乳液的安全性和耐受性进行评估.
主要方法:
- 一个随机的,开放的,为期2个周期的交叉研究,涉及52名健康的中国人.
- 静脉注射埃托米达脂肪乳液,采集血液样本进行埃托米达度分析,采用液体染色学-双重质谱法.
- 记录了药学动力学参数,包括双光谱指数 (BIS) 值;使用非分区模型分析了PK参数.
主要成果:
- 对于关键的PK参数 (Cmax,AUC0-t,AUC0-∞) 和PD参数 (BISmin,BISAUC0-60min) 的几何最小平方平均 (GLSM) 比率处于公认的生物等效范围 (80.00-125.00%).
- 测试与参考配方的比率的90%置信区间始终在生物等价性标准范围内,表明相似性.
- 没有报告严重的不良事件,这表明两种埃托米达制剂的安全性和耐受性都很好.
结论:
- 测试和参考的埃托米达脂肪乳液配方在体内表现出可比的药理动力学和药理动力学特征.
- 这些发现支持了两种埃托米达制剂的生物等价性.
- 埃托米达的两种配方都显示出良好的安全性,并且被研究参与者很好地容忍.
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