NCT00932464撤回1 期
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study To Determine The Effect Of A High-Fat Meal On The Relative Bioavailability And Pharmacokinetics Of A Single Dose Of The 240 mg Formulation Of Neratinib In Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2
研究概览
简要总结
This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women of nonchildbearing potential, age 18 to 50 years.
排除标准
- •Any previous or current clinically significant medical condition or disease.
研究组 & 干预措施
1
Experimental
Neratinib Fasted
干预措施: Neratinib (Drug)
2
Experimental
Neratinib Fed
干预措施: Neratinib (Drug)
结局指标
主要结局
Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
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