NCT00928694已完成1 期
An Open-Label, Randomized, 2-Period, Crossover Study to Determine Definitive Bioequivalence After Administration of Single 160 mg Doses of the U.S. and UK Formulations of Fenofibrate in Healthy Adult Subjects
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
- 主要终点
- Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid
研究概览
简要总结
This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is in good health
- •Subject is willing to follow all study guidelines
排除标准
- •Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe
- •Female subject is receiving oral contraceptives or hormone replacement therapy
研究组 & 干预措施
1
Active Comparator
Fenofibrate U.S. Formulation
干预措施: fenofibrate (U.S. formulation) (Drug)
2
Active Comparator
Fenofibrate UK Formulation
干预措施: fenofibrate (UK formulation) (Drug)
结局指标
主要结局
Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid
时间窗: Predose and up to 168 hours postdose
Maximum Plasma Concentration (Cmax) of Fenofibric Acid
时间窗: Predose and up to 168 hours postdose
次要结局
未报告次要终点
研究者
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