NCT02634034已完成1 期
A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers
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
- 18
- 试验地点
- 1
- 主要终点
- Area Under the Curve
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 provides written informed consent before any study-specific evaluation is performed.
- •Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
- •Subject has no clinically significant abnormalities on the basis of medical history, physical examination findings, or vital sign measurements, as judged by the Investigator.
- •Subject is able and willing to comply with the protocol and study procedures.
排除标准
- •Subject is a woman who is pregnant or breastfeeding.
- •Subject has clinically relevant abnormalities in the screening or check-in assessments.
- •Subject has received an investigational drug within 30 days before the first dose of study drug.
研究组 & 干预措施
Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)
Experimental
干预措施: A: NK-104-CR 8 mg (Drug)
Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)
Experimental
干预措施: B: Pitavastatin IR 4 mg (Drug)
NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)
Experimental
干预措施: A: NK-104-CR 8 mg (Drug)
NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)
Experimental
干预措施: B: Pitavastatin IR 4 mg (Drug)
Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)
Experimental
干预措施: C: Pitavastatin IR 8 mg (Drug)
NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)
Experimental
干预措施: C: Pitavastatin IR 8 mg (Drug)
Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)
Experimental
干预措施: A: NK-104-CR 8 mg (Drug)
Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)
Experimental
干预措施: B: Pitavastatin IR 4 mg (Drug)
Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)
Experimental
干预措施: C: Pitavastatin IR 8 mg (Drug)
结局指标
主要结局
Area Under the Curve
时间窗: 0 to 48 hours
Area Under the Curve 0 to tau
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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