NCT01642862终止1 期
A Phase I, Randomized, Open Label, Mono-centered, Prospective Study to Evaluate the Pharmacokinetics of Different Formulations and Doses of Simvastatin in Healthy Subjects and in Subjects With Celiac Disease in Remission
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Peak plasma concentration (Cmax) of simvastatin
研究概览
简要总结
The inter- and intra-variability in the pharmacokinetic parameters of different formulations and doses of simvastatin in healthy subjects and in subjects with celiac disease in remission will be evaluated. Additionally, baseline values of pharmacokinetic parameters of simvastatin for both study groups will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 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
Liquid formulation of Simvastatin
Experimental
干预措施: Simvastatin (Drug)
Tablet formulation of Simvastatin
Active Comparator
干预措施: Simvastatin (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of simvastatin
时间窗: 0, 15, 30, 60, 90, 120, 180 minutes post-dose
Determination of time-dependent concentrations of simvastatin in collected serum of each subject following oral administration of two different formulations and two different doses of simvastatin
次要结局
未报告次要终点
研究者
研究点 (1)
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