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研究领域生物医学和临床科学药理学和制药科学药物基因组学
在禁食和食条件下对健康的中国人进行两种配方的生物等价性研究

在禁食和食条件下对健康的中国人进行两种配方的生物等价性研究

Yinglin Yang ¹, Jiejing Kai ^2,3, Duo Lv ^2,3, Huili Zhou ^2,3, Yan Yu ¹, Jianzhong Shentu ^2,3, Guolan Wu ^4,5,6

Yinglin Yang ¹, Jiejing Kai ^2,3, Duo Lv ^2,3

¹Department of Nursing, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
²Department of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
³Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
⁴Department of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. 1508072@zju.edu.cn.
⁵Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. 1508072@zju.edu.cn.
⁶The First Affiliated Hospital, Zhejiang University School of Medicine, Qingchun Road No. 79, Hangzhou, Zhejiang, China. 1508072@zju.edu.cn.

⁰Department of Nursing, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Drugs in R&d +

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2025年八月22日

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在PubMed上查看摘要

概括

此摘要是机器生成的。

这项研究证实了试验和参考flunarizine化物囊的生物等价性. 在禁食和食条件下,这两种配方都被发现是安全的,并且在健康的中国受试者中耐受良好.

科学领域

药理学
临床药房

背景情况

弗鲁纳化是一种用于偏头痛和头的通道阻断剂.
了解其生物等效对于治疗效果至关重要.

研究的目的

为了比较试验和参考flunarizine化物囊的生物等价性,药理动力学和安全性.
评估食物对弗鲁纳利津的吸收的影响.

主要方法

一个随机的,开放的,两期的交叉生物等价性研究.
在健康的中国人中,在禁食和食条件下单次服用5mg口服剂量.
使用非分组方法分析的药理学参数;通过90%的置信区间评估生物等价性.

主要成果

在禁食和食条件下,试验中的弗鲁纳化物配方与参考配方具有生物等价性.
高脂肪饮食将Tmax延迟2.5小时,并增加了20%的暴露.
这两种配方都能耐受,没有报告严重的不良反应.

结论

测试和参考弗鲁纳利津化囊显示生物等价性.
药物是安全的,耐受性良好,可预测的药理学行为受食物摄入的影响.

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