Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF) Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose) in Healthy Female Subjects (an Open-label, Randomised, Single-dose, Three-period, Three-sequence Crossover Study at Two Different Dose Strengths)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Cmax (maximum measured concentration of the analyte in plasma)
研究概览
简要总结
The primary objective is to investigate the relative bioavailability of two newly developed tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is the comparison of several pharmacokinetic parameters between the treatments.
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
- Female
- 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
2 BI 1060469 low dose
iFF followed by TF1 followed by TF2
干预措施: BI 1060469, TF1, Reference (Drug)
2 BI 1060469 high dose
iFF followed by TF1 followed by TF2
干预措施: BI 1060469, iFF, Test (Drug)
2 BI 1060469 low dose
iFF followed by TF1 followed by TF2
干预措施: BI 1060469, iFF, Test (Drug)
3 BI 1060469 low dose
TF2 followed by iFF followed by TF1
干预措施: BI 1060469, TF1, Reference (Drug)
3 BI 1060469 low dose
TF2 followed by iFF followed by TF1
干预措施: BI 1060469, TF2, Test (Drug)
3 BI 1060469 low dose
TF2 followed by iFF followed by TF1
干预措施: BI 1060469, iFF, Test (Drug)
1 BI 1060469 high dose
TF1 followed by TF2 followed by iFF
干预措施: BI 1060469, iFF, Test (Drug)
1 BI 1060469 high dose
TF1 followed by TF2 followed by iFF
干预措施: BI 1060469, TF1, Reference (Drug)
1 BI 1060469 high dose
TF1 followed by TF2 followed by iFF
干预措施: BI 1060469, TF2, Test (Drug)
2 BI 1060469 high dose
iFF followed by TF1 followed by TF2
干预措施: BI 1060469, TF2, Test (Drug)
2 BI 1060469 high dose
iFF followed by TF1 followed by TF2
干预措施: BI 1060469, TF1, Reference (Drug)
3 BI 1060469 high dose
TF2 followed by iFF followed by TF1
干预措施: BI 1060469, TF2, Test (Drug)
3 BI 1060469 high dose
TF2 followed by iFF followed by TF1
干预措施: BI 1060469, iFF, Test (Drug)
3 BI 1060469 high dose
TF2 followed by iFF followed by TF1
干预措施: BI 1060469, TF1, Reference (Drug)
1 BI 1060469 low dose
TF1 followed by TF2 followed by iFF
干预措施: BI 1060469, iFF, Test (Drug)
1 BI 1060469 low dose
TF1 followed by TF2 followed by iFF
干预措施: BI 1060469, TF1, Reference (Drug)
1 BI 1060469 low dose
TF1 followed by TF2 followed by iFF
干预措施: BI 1060469, TF2, Test (Drug)
2 BI 1060469 low dose
iFF followed by TF1 followed by TF2
干预措施: BI 1060469, TF2, Test (Drug)
结局指标
主要结局
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: up to 72 h
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
时间窗: up to 72 h
次要结局
- AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 72 h)