NCT00498745已完成1 期
A Single Dose Bioavailability Study of 2 New Formulations of HKI-272 (240 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development.
研究概览
简要总结
To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 male and female subjects aged 18 to 50 years.
- •Women of nonchildbearing potential (WONCBP)
排除标准
- 未提供
结局指标
主要结局
The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid TumorsTumorsCancerNeoplasmNCT01155713Novartis Pharmaceuticals63
已完成
1 期
Bioavailability and Food Effect Study of TKI258 (CSF Capsules vs. FMI Capsules)in Adult Patients With Advanced Solid TumorsNeoplasmsTumorsCancerNCT01030055Novartis Pharmaceuticals60
已完成
1 期
Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult SubjectsHealthyNCT00499538Wyeth is now a wholly owned subsidiary of Pfizer40
已完成
1 期
Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I in Healthy VolunteersHealthyNCT02182414Boehringer Ingelheim42
已完成
1 期
Relative Bioavailability Study of Candesartan Cilexetil Under Fasting ConditionsCardiovascular DiseaseNCT02254447GlaxoSmithKline18