Relative Bioavailability of 10 mcg Olodaterol (Solution for Inhalation Administered With the Respimat) at Steady State Alone or in Combination With Multiple Doses of 400 mg q.d. Ketoconazole (Tablet) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum Concentration at Steady State (Cmax,ss)
研究概览
简要总结
This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（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
BI 1744 10 mcg
solution for oral inhalation
干预措施: BI 1744 (Drug)
BI 1744 10 mcg
solution for oral inhalation
干预措施: Ketoconazole (Drug)
Ketoconazole 400 mg
tablet
干预措施: BI 1744 (Drug)
Ketoconazole 400 mg
tablet
干预措施: Ketoconazole (Drug)
结局指标
主要结局
Maximum Concentration at Steady State (Cmax,ss)
时间窗: Day 8 of period 1 and day 14 of period 2
Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)
时间窗: Day 8 of period 1 and day 14 of period 2
AUC0-1,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=1 hour at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
次要结局
- Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)(Day 8 of period 1 and day 14 of period 2)
- Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG(First administration of trial medication until 6 days after last administration of trial medication)
- Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)(Day 8 of period 1 and day 14 of period 2)
- Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss)(Day 8 of period 1 and day 14 of period 2)
- Assessment of Tolerability by the Investigator(End of period 1 and end of period 2)
- Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)(Day 8 of period 1 and day 14 of period 2)