NCT01383330Unknown1 期
Phase 1 Study of Daewon-ES(A) & Daewon-ES(B) in Healthy Male Volunteers Under Fed Condition
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 15
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(A) 625mg/5ml, Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males aged 20 to 55 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
Megace
Experimental
800mg
干预措施: megace (Drug)
DW-ES(A)
Active Comparator
625mg
干预措施: DW-ES(A) (Drug)
DW-ES(B)
Active Comparator
625mg
干预措施: DW-ES(B) (Drug)
研究者
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