NCT06655220已完成1 期
Investigation of the Effect of BI 1815368 on the Pharmacokinetics of Metformin Following Multiple Oral Administration in Healthy Subjects (an Open-label, Randomised, Two-way Crossover Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- AUC τ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
研究概览
简要总结
The main objective of this trial is to investigate the effect on the exposure of metformin in plasma when administered as an oral multiple dose together with multiple oral doses of BI 1815368 (Test, T) as compared to when metformin is administered as an oral multiple dose alone (Reference, R).
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
- 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
Metformin hydrochloride alone (reference) followed by metformin hydrochloride + BI 1815368 (Test)
Experimental
干预措施: Metformin hydrochloride (Drug)
Metformin hydrochloride alone (reference) followed by metformin hydrochloride + BI 1815368 (Test)
Experimental
干预措施: BI 1815368 (Drug)
Metformin hydrochloride + BI 1815368 (Test) followed by metformin hydrochloride alone (reference)
Experimental
干预措施: Metformin hydrochloride (Drug)
Metformin hydrochloride + BI 1815368 (Test) followed by metformin hydrochloride alone (reference)
Experimental
干预措施: BI 1815368 (Drug)
结局指标
主要结局
AUC τ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
时间窗: Up to 2 days after last dose administration
C max,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
时间窗: Up to 2 days after last dose administration
次要结局
- CL R,ss (renal clearance of the analyte from plasma at steady state)(Up to 2 days after last dose administration)
研究者
研究点 (1)
Loading locations...
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