The Effect of BI 3000202 on the Pharmacokinetics of Rosuvastatin and Digoxin Given as a Cocktail - an Open-label, Non-randomised, 2-period Fixed-sequence Trial in Healthy Male and Female Trial Participants
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
- Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
研究概览
简要总结
The objective of this trial is to assess the effect of BI 3000202 on the pharmacokinetics of rosuvastatin and digoxin given as a cocktail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure BP, pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 55 years (inclusive)
- •Body mass index (BMI) of 18.5 to 29.9 kg / m^2 (inclusive)
- •Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (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.
研究组 & 干预措施
Cocktail (Reference) then BI 3000202-Cocktail (Test)
Cocktail consisting of rosuvastatin and digoxin.
干预措施: BI 3000202 (Drug)
Cocktail (Reference) then BI 3000202-Cocktail (Test)
Cocktail consisting of rosuvastatin and digoxin.
干预措施: Rosuvastatin (Drug)
Cocktail (Reference) then BI 3000202-Cocktail (Test)
Cocktail consisting of rosuvastatin and digoxin.
干预措施: Digoxin (Drug)
结局指标
主要结局
Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: Up to Day 7
Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: Up to Day 7
Maximum measured concentration of rosuvastatin in plasma (Cmax)
时间窗: Up to Day 7
Maximum measured concentration of digoxin in plasma (Cmax)
时间窗: Up to Day 7
次要结局
- Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)(Up to Day 7)
- Area under the concentration-time curve of digoxin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)(Up to Day 7)