Effect of Rifampicin on the Pharmacokinetics of BI 409306 Following Oral Administration in Healthy Male Subjects (an Open-label, Two-period, Fixed Sequence Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
研究概览
简要总结
The primary objective of this trial is to investigate the relative bioavailability of BI 409306 tablets with prior 7-day intake of rifampicin tablets (Test, T) compared to BI 409306 tablets without prior administration of rifampicin (Reference, R) following oral administration in healthy male subjects.
The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments. The secondary objectives will be assessed by descriptive statistics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 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 409306 (R), then BI 409306 after pretreatment with rifampicin (T)
Subjects were administered during Period 1 on Day 1/Visit 2 a single dose of 50 milligrams (mg) of BI 409306 film-coated tablet orally with 240 millilitre (mL) of water (reference treatment, R).
On Days -7 to -1 /Visit 3 of Period 2 participants were administered rifampicin 600 mg Eremfat® film-coated tablet orally with 240 mL of water once per day during the evenings. Afterwards on Day 1/Visit 3, participants were administered a single dose of 50 mg BI 409306 orally approximately 14 hours after the last rifampicin dose (test treatment, T).
Due to the short half-life of BI 409306, trial period 2 directly followed trial period 1 without a wash-out period.
干预措施: BI 409306 (Drug)
BI 409306 (R), then BI 409306 after pretreatment with rifampicin (T)
Subjects were administered during Period 1 on Day 1/Visit 2 a single dose of 50 milligrams (mg) of BI 409306 film-coated tablet orally with 240 millilitre (mL) of water (reference treatment, R).
On Days -7 to -1 /Visit 3 of Period 2 participants were administered rifampicin 600 mg Eremfat® film-coated tablet orally with 240 mL of water once per day during the evenings. Afterwards on Day 1/Visit 3, participants were administered a single dose of 50 mg BI 409306 orally approximately 14 hours after the last rifampicin dose (test treatment, T).
Due to the short half-life of BI 409306, trial period 2 directly followed trial period 1 without a wash-out period.
干预措施: Rifampicin (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: Within 3 hours (h) before and 0.333h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 11h, 12h, 24h after drug administration.
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
Maximum Measured Concentration of BI 409306 in Plasma (Cmax)
时间窗: Within 3 hours (h) before and 0.333h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 11h, 12h, 24h after drug administration.
Maximum measured concentration of BI 409306 in plasma (Cmax) is reported.
次要结局
- Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Within 3 hours (h) before and 0.333h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 11h, 12h, 24h after drug administration.)