Relative Bioavailability of a Single Oral Dose of Digoxin, Furosemide, Metformin, and Rosuvastatin Given Alone and All Together as a Cocktail, and Investigation of the Effect of Increased Doses of Metformin or Furosemide on Relative Bioavailability of the Other Cocktail Compounds in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Digoxin, Metformin, Rosuvastatin: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
研究概览
简要总结
To investigate the mutual interaction potential of digoxin, furosemide, metformin, and rosuvastatin when given alone or together as a cocktail, and to investigate the effect of high doses of metformin or furosemide on pharmacokinetics of the other cocktail compounds
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
A (Reference 1) Digoxin
1 tablet as single dose, fasted
干预措施: Digoxin (Drug)
B (Reference 2) Furosemide
oral solution, as single dose, fasted
干预措施: Furosemide (Drug)
C (Reference 3) Metformin hydrochloride
1 film-coated tablet as single dose, fasted
干预措施: Metformin hydrochloride (Drug)
D (Reference 4) Rosuvastatin
1 film-coated tablet as single dose, fasted
干预措施: Rosuvastatin (Drug)
E (Test) 1
Digoxin (1 tablet), Furosemide (0.5 mL oral solution), Metformin hydrochloride (1 film-coated tablet), Rosuvastatin (1 film-coated tablet), fasted
干预措施: Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin (Drug)
F (Test 2)
Digoxin (1 tablet), Furosemide (0.5 mL oral solution), Metformin hydrochloride (2 film-coated tablets), Rosuvastatin (1 film-coated tablet), fasted
干预措施: Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin (Drug)
G (Test 3)
Digoxin (1 tablet), Furosemide (2.0 mL oral solution), Metformin hydrochloride (1 film-coated tablet), Rosuvastatin (1 film-coated tablet), fasted
干预措施: Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin (Drug)
结局指标
主要结局
Digoxin, Metformin, Rosuvastatin: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
时间窗: up to 96 hours
Furosemide: Cmax (maximum measured concentration of the analyte in plasma)
时间窗: up to 36 hours
Digoxin, Metformin, Rosuvastatin: Cmax (maximum measured concentration of the analyte in plasma)
时间窗: up to 96 hours
Furosemide: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
时间窗: up to 36 hours
次要结局
- Digoxin, Metformin, Rosuvastatin: AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 96 hours)
- Furosemide: AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 36 hours)