NCT01083290已完成1 期
Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets in Healthy Subjects Under Fasting Conditions.
适应症
干预措施
相关药物
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
- Cmax, AUC0-t and AUC0-inf of Spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone in plasma
研究概览
简要总结
Objective is to investigate pharmacokinetics and to estimate the level of dose linearity of spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone from Spironolactone 25 mg, 50 mg and 100 mg Tablets
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Subjects with normal findings as determined by baseline history, physical examination and vital signs, haemogram, biochemistry, infectious disease screening, urinalysis, 12 lead ECG
排除标准
- •Any condition requiring regular concomitant medication or likely to need any concomitant medication during the study.
研究组 & 干预措施
Order of strenghts; 25 mg, 50 mg, 100 mg
Experimental
干预措施: Spironolactone (Drug)
Order of strenghts; 50 mg, 100 mg, 25 mg
Experimental
干预措施: Spironolactone (Drug)
Order of strenghts; 100 mg, 25 mg, 50 mg
Experimental
干预措施: Spironolactone (Drug)
结局指标
主要结局
Cmax, AUC0-t and AUC0-inf of Spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone in plasma
时间窗: up to 72 h after the study drug administration
次要结局
未报告次要终点
研究者
研究点 (1)
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