NCT01761513已完成1 期
A Randomized,Open Label,Active-controlled, Multiple Dosing and Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of YH4808 After Postprandial Oral Administration in Healthy Volunteers
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2012年11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
- 21
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve of YH4808
研究概览
简要总结
A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
- •Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
- •Subject who shows negative reaction of UBT(Urea Breath Test)
- •Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration
- •Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
- •Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
排除标准
- •Subject who is hypersensitive to components contained in YH4808 or this drug
- •Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
- •Subject who has history of surgical operation or diseases related to gastrointestinal symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina)
- •Other exclusions apply
研究组 & 干预措施
Sequence 1
Experimental
干预措施: YH4808 (Drug)
Sequence 2
Experimental
干预措施: YH4808 (Drug)
Sequence 3
Active Comparator
干预措施: YH4808 (Drug)
Sequence 4
Active Comparator
干预措施: YH4808 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve of YH4808
时间窗: Blood sampling during 0 ~ 24 hrs after administration
Peak plasma concentration of YH4808
时间窗: Blood sampling during 0~24 hrs after administration
次要结局
- Time to reach peak plasma concentration of YH4808(Blood sampling during 0 ~ 24 hrs after administration)
研究者
研究点 (1)
Loading locations...
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