[延长释放西尔代纳菲尔的药理动力学研究]
B Kurta I1,2,3, V Zakharova A1,2,3, F Guranda D1,2,3
1Central Clinical Hospital RZD Medicine Moscow Russia.
这项研究将Vildegra与Viagra进行了比较,发现类似的药理动力学和安全性. 维尔德格拉的疗效和耐受性与原始伟哥药物相比相当.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床药理学 临床药理学
- 药物开发 药物开发
背景情况:
- 勃起功能障碍是一种常见的疾病,影响了许多男性.
- 西尔德纳菲尔酸盐是用于勃起功能障碍的广泛使用的药物.
- 维尔德格拉是俄罗斯联邦注册的基于西尔代纳菲尔的药物.
研究的目的:
- 将Vildegra的药理动力学特征与Viagra的现有文献数据进行比较.
- 在健康志愿者中评估Vildegra的安全性和耐受性.
主要方法:
- 在48名健康男性志愿者中进行前性开放性研究.
- 在空腹时单次口服Vildegra剂量.
- 血液样本用HPLC-MS/MS分析了西尔德纳菲尔和N-脱甲基西尔德纳菲尔度.
- 使用无模型方法计算的药理动力学参数.
主要成果:
- 维尔德格拉对西尔代纳菲尔及其代谢物的AUC0-t,AUC0-和Cmax值与维亚格拉的文献数据一致.
- 维尔德格拉的tmax和t1/2略高,可能是由于其延长释放配方.
- 在10名志愿者 (21%),报告了20次不良事件 (AE),所有事件都没有严重并发症.
结论:
- 维尔德格拉具有与伟哥可比的药理动力学特性. 维尔德格拉具有与伟哥可比的药理动力学特性.
- 该药物表现出良好的耐受性和令人满意的安全性.
- 根据这些发现,Vildegra可以被认为是伟哥的可行替代品.
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