NCT01232049已完成1 期
A Randomized, Open-label, Multiple Dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety Between Pitavastatin and Valsartan in Healthy Male 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
- 24
- 试验地点
- 1
- 主要终点
- Safety (normal results for safety tests)
研究概览
简要总结
This study is designed to evaluate a pharmacokinetic drug interaction and safety between Pitavastatin and Valsartan in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males aged 20 to 50 years at screening.
- •No significant congenital/chronic disease. No symptoms in physical examination.
- •Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
- •Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.
排除标准
- •History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
- •History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
- •History of known hypersensitivity to drugs including valsartan and pitavastatin.
研究组 & 干预措施
A
Experimental
Pitavastatin 4mg
干预措施: Multiple Oral Dose of (Drug)
B
Experimental
Valsartan 320mg
干预措施: Multiple Oral Dose of (Drug)
C
Experimental
Pitavastatin 4mg + Valsartan 320mg
干预措施: Multiple Oral Dose of (Drug)
结局指标
主要结局
Safety (normal results for safety tests)
时间窗: 39days
Adverse events Physical examination, vital signs
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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