NCT07100964已完成1 期
The Effect of Multiple Oral Doses of Carbamazepine on the Single-oral-dose Pharmacokinetics of Nerandomilast in Healthy Male Trial Participants (an Open-label, Two-treatment, Two- Period Fixed Sequence Trial)
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
- 16
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
研究概览
简要总结
The main objective of this trial is to investigate the effect of carbamazepine on pharmacokinetics of nerandomilast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
Nerandomilast alone followed by nerandomilast + carbamazepine
Experimental
干预措施: nerandomilast (Drug)
Nerandomilast alone followed by nerandomilast + carbamazepine
Experimental
干预措施: carbamazepine (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
时间窗: Up to 30 days
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: Up to 30 days
次要结局
- Area under the Plasma Concentration Curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)(Up to 30 days)
研究者
研究点 (1)
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