NCT00432627已完成1 期
An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of 20 mg/kg Oral Deferasirox in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of deferasirox and its metabolites
研究概览
简要总结
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mild hepatic impaired
Experimental
干预措施: Deferasirox (Drug)
Moderate hepatic impaired
Experimental
干预措施: Deferasirox (Drug)
Severe hepatic impaired
Experimental
干预措施: Deferasirox (Drug)
Healthy volunteers
Experimental
Controlled group
干预措施: Deferasirox (Drug)
结局指标
主要结局
Pharmacokinetics of deferasirox and its metabolites
时间窗: at FPFV and at LPLV
次要结局
- Safety and tolerability of deferasirox assessed by adverse events(at FPFV and at LPLV)
研究者
研究点 (1)
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