The Effect of Different Doses of Metformin or Furosemide on Rosuvastatin Pharmacokinetics Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Six-way Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area Under the Curve of Rosuvastatin From 0 to the Last Quantifiable Data Point (AUC0-tz)
研究概览
简要总结
The primary objective of this trial is to investigate the relative bioavailability of rosuvastatin when given alone (Reference treatment, R) compared to when given together with one of the three different doses of metformin (10 mg, Test treatment 1 (T1); 50 mg (T2); 500 mg (T3)) or one of the two doses of furosemide (1 mg (T4); 5 mg (T5)).
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 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
R (Reference) Rosuvastatin
1film-coated tablet as single dose, fasted
干预措施: Rosuvastatin (Drug)
T1 (Test 1) Rosuvastatin + Metformin HCl
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (10 mg) as single dose, fasted
干预措施: Rosuvastatin (Drug)
T1 (Test 1) Rosuvastatin + Metformin HCl
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (10 mg) as single dose, fasted
干预措施: Metformin HCl (Drug)
T2 (Test 2) Rosuvastatin + Metformin HCl
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (50 mg) as single dose, fasted
干预措施: Rosuvastatin (Drug)
T2 (Test 2) Rosuvastatin + Metformin HCl
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (50 mg) as single dose, fasted
干预措施: Metformin HCl (Drug)
T3 (Test 3) Rosuvastatin + Metformin HCl
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (500 mg) as single dose, fasted
干预措施: Rosuvastatin (Drug)
T3 (Test 3) Rosuvastatin + Metformin HCl
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (500 mg) as single dose, fasted
干预措施: Metformin HCl (Drug)
T4 (Test 4) Rosuvastatin + Furosemide
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (1 mg) as single dose, fasted
干预措施: Rosuvastatin (Drug)
T4 (Test 4) Rosuvastatin + Furosemide
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (1 mg) as single dose, fasted
干预措施: Furosemide (Drug)
T5 (Test 5) Rosuvastatin + Furosemide
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (5 mg) as single dose, fasted
干预措施: Rosuvastatin (Drug)
T5 (Test 5) Rosuvastatin + Furosemide
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (5 mg) as single dose, fasted
干预措施: Furosemide (Drug)
结局指标
主要结局
Area Under the Curve of Rosuvastatin From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.
This outcome measure presents the area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Maximum Concentration of Rosuvastatin (Cmax)
时间窗: Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.
This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax).
次要结局
- Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC0-∞)(Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.)