A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Time-course urinary sodium excretion calculated on the Day 1 of each study period
研究概览
简要总结
A single centre, open, randomized, placebo controlled, 3 period cross-over study to evaluate the effects of single oral doses of pioglitazone 45mg, rosiglitazone 8mg and placebo on urinary sodium excretion in 12 healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 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
1
pioglitazone 45 mg
干预措施: pioglitazone/rosiglitazone/placebo (Drug)
1
pioglitazone 45 mg
干预措施: rosiglitazone/pioglitazone/placebo (Drug)
1
pioglitazone 45 mg
干预措施: placebo/pioglitazone/rosiglitazone (Drug)
1
pioglitazone 45 mg
干预措施: pioglitazone/placebo/rosiglitazone (Drug)
1
pioglitazone 45 mg
干预措施: rosiglitazone/placebo/pioglitazone (Drug)
1
pioglitazone 45 mg
干预措施: placebo/rosiglitazone/pioglitazone (Drug)
2
Rosiglitazone 8 mg
干预措施: pioglitazone/rosiglitazone/placebo (Drug)
2
Rosiglitazone 8 mg
干预措施: rosiglitazone/pioglitazone/placebo (Drug)
2
Rosiglitazone 8 mg
干预措施: placebo/pioglitazone/rosiglitazone (Drug)
2
Rosiglitazone 8 mg
干预措施: pioglitazone/placebo/rosiglitazone (Drug)
2
Rosiglitazone 8 mg
干预措施: rosiglitazone/placebo/pioglitazone (Drug)
2
Rosiglitazone 8 mg
干预措施: placebo/rosiglitazone/pioglitazone (Drug)
3
Placebo
干预措施: pioglitazone/rosiglitazone/placebo (Drug)
3
Placebo
干预措施: rosiglitazone/pioglitazone/placebo (Drug)
3
Placebo
干预措施: placebo/pioglitazone/rosiglitazone (Drug)
3
Placebo
干预措施: pioglitazone/placebo/rosiglitazone (Drug)
3
Placebo
干预措施: rosiglitazone/placebo/pioglitazone (Drug)
3
Placebo
干预措施: placebo/rosiglitazone/pioglitazone (Drug)
结局指标
主要结局
Time-course urinary sodium excretion calculated on the Day 1 of each study period
时间窗: 0-6 hours
Time-course absolute urinary sodium excretion calculated on the Day 1 of each study period
时间窗: 0-6 hours
次要结局
- Sodium clearance on Day 1 of each study period(0-6 hours)
- Creatinine clearance calculated on Day 1 of each study period(0-6 hours)