NCT01548157已完成1 期
A Randomized, Open Label, Single Dose, 2X2 Cross-over Study to Compare Pharmacokinetics Between Rosuvastatin 10mg and Omega-3 1g Co-administration and HCP1007 in Healthy Male Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area Under Curve(AUC) last
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.
详细描述
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.
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
- •BMI of >20kg/m2 and <26kg/m2 subject
排除标准
- •Use of any prescription medication within 14 days prior to Day 1
- •Use of any medication within 7 days prior to Day 1
- •Participation in another clinical study within 60 days prior to start of study drug administration
研究组 & 干预措施
HCP1007
Experimental
HCP1007
干预措施: HCP1007 / omarco and crestor (Drug)
omarco and crestor
Active Comparator
Rosuvastatin plus Omega-3
干预措施: HCP1007 / omarco and crestor (Drug)
结局指标
主要结局
Area Under Curve(AUC) last
时间窗: 0,0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,48hours post-dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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