NCT01555398已完成1 期
Open-label, Randomized Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Fenofibric Acid for HIP0901 Capsule in Healthy Male Subjects
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUC of Fenofibric acid
研究概览
简要总结
The purpose of this study is to evaluate the effect of food on the pharmacokinetic characteristics of fenofibric acid for HIP0901 capsule.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, age between 20 and 45
- •Informed of the investigational nature of this study and voluntarily agree to participate in this study
- •Weight>50kg, BMI of >18kg/m2 and <27kg/m2 subject
排除标准
- •Acute disease within 28 days prior to start of study drug administration
- •Use of any prescription medication within 14 days prior to Day 1
- •Use of any medication within 7 days prior to Day 1
- •Has a severe medical history of hypersensitivity to fibric acid derivative
- •Participation in another clinical study within 30 days prior to start of study drug administration
结局指标
主要结局
AUC of Fenofibric acid
时间窗: 0-96 hrs
Cmax of Fenofibric acid
时间窗: 0-96 hrs
次要结局
未报告次要终点
研究者
研究点 (1)
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