NCT01456624已完成1 期
A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of DW-ES(B) and Megace® Under Fasting and Fed Conditions in Healthy Male 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
- 56
- 试验地点
- 1
- 主要终点
- Safety (normal results for safety tests)
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fasting and fed condition.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males aged 20 to 40 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.
研究组 & 干预措施
Megace / Fasting condition
Active Comparator
800mg
干预措施: Megace (Drug)
DW-ES(B) / Fasting condition
Experimental
625mg
干预措施: DW-ES(B) (Drug)
Megace / Fed condition
Active Comparator
800mg
干预措施: Megace (Drug)
DW-ES(B) / Fed condition
Experimental
625mg
干预措施: DW-ES(B) (Drug)
结局指标
主要结局
Safety (normal results for safety tests)
时间窗: 30days
Adverse events Physical examination, vital signs
次要结局
未报告次要终点
研究者
Gyu-Jeong Noh
Professor
Asan Medical Center
研究点 (1)
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