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在健康的中国人群中使用新型药理动力学终点评估阿卡的生物等价性

Linling Que¹, Zhenzhong Qian¹, Xuemei Xiang¹

¹Drug Clinical Trial Institution, Wuxi People's Hospital Affiliated to Nanjing Medical University, Wuxi, Jiangsu, China.

Clinical pharmacology in drug development

|January 10, 2024

概括

这项研究证实了在健康的中国志愿者中使用新型药学动力学 (PD) 参数的阿卡尔生物等价性 (BE). 试验和参考药物显示了可比的安全性和耐受性,验证了糖尿病管理的新PD终点.

科学领域:

药理学和治疗学药理学和治疗学
临床药房临床药房
内分泌学在内分泌学.

背景情况:

阿卡尔是一种α-葡萄糖酶抑制剂,通过控制食后高血糖,对控制2型糖尿病至关重要.
最近的试点研究表明,新的药理动力学 (PD) 参数对于阿卡生物等价性 (BE) 评估是有效的.
由于缺乏利用这些新PD参数对acarbose BE进行的关键研究,需要进一步调查.

研究的目的:

通过使用新的药理动力学 (PD) 参数来评估阿卡尔的生物等价性 (BE).
评估健康参与者的PD参数校正的适宜性和敏感性.

主要方法:

这是一项开放的,随机的,为期2个周期的交叉研究,涉及64名健康的中国志愿者.
基准 (R) 或试验 (T) 阿卡尔 (2x50毫克口服) 给药,一周的洗期.
血清葡萄糖和胰岛素度的测量在治疗糖和在同时服用糖/糖后.

主要成果:

调整的最大血清葡萄糖度 (102.9%) 和调整的AUC (0-2h,r) (105.3%) 的几何平均比值都在可接受的范围内.
这些调整后的PD参数的90%置信区间也符合生物等价性标准.
试验和参考糖之间的不良事件发生率是可比的,观察到良好的耐受性.

结论:

新的修复药理动力学 (PD) 参数显示了对评估阿卡尔生物等价性 (BE) 的增强适用性和灵敏性.
根据这些新的PD参数,测试和基准糖配方被发现是生物等价的.
这两种阿卡尔博斯配方在健康参与者中都表现出良好的安全性和耐受性.

关键词:

这种药物是阿卡尔糖 (acarbose).生物等价性生物等价性降低血糖的影响.一个人的差异是个人的差异.药理动力学是药理动力学的一个方面.

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