NCT00427505已完成1 期
An Open-label, One-sequence Cross-over Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 22
- 主要终点
- To assess the effect of deferasirox on the pharmacokinetics of midazolam
研究概览
简要总结
This is a study to investigate the pharmacokinetics of deferasirox
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good health
- •No evidence of iron deficiency
- •Weight between 50 and 100 kg
- •Body Mass Index between 19 and 29 kg/m2
排除标准
- •Use of certain drugs, herbal remedies or nutrients
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
To assess the effect of deferasirox on the pharmacokinetics of midazolam
次要结局
- Safety assessed by adverse events (AEs)
研究者
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