A Study to Investigate the Pharmacokinetic Drug-drug Interaction Following Oral Administration of BI 409306 and Donepezil in Healthy Male and Female Subjects
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
- Part 2: AUC0-tz of Donepezil
研究概览
简要总结
Part I:
To investigate whether and to what extent donepezil affects single dose pharmacokinetics of BI 409306
Part II:
To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics of donepezil
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
- 15 Years 至 55 Years（Child, 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
Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1)
Subjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)).
干预措施: BI 409306 (Drug)
Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1)
Subjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)).
干预措施: Donepezil (Drug)
Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2)
Subjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2).
干预措施: BI 409306 (Drug)
Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2)
Subjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2).
干预措施: Donepezil (Drug)
Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)
Subjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)).
干预措施: BI 409306 (Drug)
Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)
Subjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)).
干预措施: Donepezil (Drug)
结局指标
主要结局
Part 2: AUC0-tz of Donepezil
时间窗: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.
Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point.
Part 1: Cmax of BI 409306
时间窗: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.
Maximum measured concentration of the BI 409306 in plasma.
Part 1: AUC0-tz of BI 409306
时间窗: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter.
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point.
Part 2: Cmax of Donepezil
时间窗: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.
Maximum measured concentration of the donepezil in plasma.
次要结局
- Part 1: AUC 0-infinity of BI 409306(At approximate 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.)
- Part 2: AUC0-infinity of Donepezil(At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.)