CTIS2024-511245-18-00进行中（未招募）1 期
Relative bioavailability of two different formulations of nerandomilast and investigation of the food effect on new formulation following oral administration in healthy adult male and female subjects (an open-label, randomised, single-dose, three-way crossover trial) - 1305-0029
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests, Age of 18 to 55 years (inclusive), BMI of 18.5 to 29.9 kg/m² (inclusive), Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial, Further inclusion criteria apply.
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator, Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm, Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, Any evidence of a concomitant disease assessed as clinically relevant by the investigator, Further exclusion criteria apply.
研究者
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