NCT07081932已完成1 期
The Effect of Multiple Oral Doses of Bosentan on the Single Oral Dose Pharmacokinetics of Nerandomilast in Healthy Male Subjects (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 (AUC0-tz)
研究概览
简要总结
The main objective of this trial is to investigate the effect of bosentan, a moderate Cytochrome P450 (CYP) 3A inducer on the single dose 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 + bosentan
Experimental
干预措施: Nerandomilast (Drug)
Nerandomilast alone followed by nerandomilast + bosentan
Experimental
干预措施: Bosentan (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 (AUC0-tz)
时间窗: Up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: Up to 4 days
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to 4 days)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue DiseaseHypertension, PulmonaryConnective Tissue DiseaseNCT00864201Hamilton Health Sciences Corporation10
进行中（未招募）
不适用
Safety and efficacy study of bosentan in progressive pulmonary sarcoidosis - BOPSACProgressive pulmonary sarcoidosisMedDRA version: 9.1Level: PTClassification code 10037430Term: Pulmonary sarcoidosisEUCTR2007-005117-18-ATMedical University of Vienna, Department of Clinical Pharmacology
已完成
2 期
Phase II Trial of Pentostatin and Targeted BusulfanHematologic MalignanciesNCT00496340H. Lee Moffitt Cancer Center and Research Institute42
已完成
3 期
Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary HypertensionChronic Thromboembolic Pulmonary HypertensionNCT00313222Actelion157
已完成
1 期
Influence of Bosentan on the Pharmacokinetics of NintedanibHealthyNCT02667704Boehringer Ingelheim13