NCT01876615已完成1 期
A Randomized, Open-Label, Single-dosing and Cross-over Clinical Trial to Investigate the Safety and Pharmacokinetic Drug-Drug Interaction of YH4808 and Diclofenac in Healthy Male Volunteers
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2013年7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
- 49
- 试验地点
- 1
- 主要终点
- AUClast of YH4808
研究概览
简要总结
The objective of this study is to compare pharmacokinetics after single oral administration of YH4808 and Diclofenac each separately versus coadministration of YH4808 and Diclofenac in healthy male volunteers
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male age 20 to 45 over 55kg with Ideal body weight(IBW)
- •No clinically important abnormal physical findings at the screening examination
- •Subject who has no congential, chronic disease and disease symptoms in medical examination result
- •Subject who is judged to be eligible by principal inverstigator or sub-investigator according to various reasons includiong ther abnorminal test results(clinical laboratory test, 12-lead GCG etc)
- •Ability to communicate well with the inverstigator and to comply with the requremetns of the entire study
- •Willingness to give written informed consent(prior to any study-related procedures beinging performed) and to be able to adhere to the study restrictions and examination schedule
排除标准
- •Suject 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 is hypersensitive to components contained in YH4808 or declofenac or related drug(ex. rebamipide, revaprazan, NSID etc)
- •Medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery)
- •Subject who has history of drug dependence or using that drug
- •Subject who had taken usual dose of any prescription durgs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment
- •Subject who participated in antoher clinical trial within 2 monthes before enrolling in this study
- •subject who donated whole blood within 2 months or component blood within 1 month before the treatment
- •Subject who drank over 21unit/week(1 unit= 10g of alcohol) or were not able to refrain from drinking alcohol during study days
- •Subject who stopped smoking within 3 months before the treatment or detected cotinine in urine test
- •Subject with clinically significant observations considered as unsuitable based on medical judgment by the investigators
研究组 & 干预措施
YH4808 or Diclofenac or YH4808+Diclofenac(arm 1)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808+Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac(arm 1)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808 (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac(arm 1)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm 2)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808 (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm 2)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm 2)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808+Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm 3)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808 (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm 3)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm 3)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808+Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm 4)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808 (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm 4)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm 4)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808+Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm5)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808 (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm5)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm5)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808+Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm6)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808 (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm6)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: Diclofenac (Drug)
YH4808 or Diclofenac or YH4808+Diclofenac (arm6)
Experimental
6 arm, 3 Sequence design
- YH4808 or Diclofenac or YH4808+Diclofenac
- 3 week wash out period is between each period.
干预措施: YH4808+Diclofenac (Drug)
结局指标
主要结局
AUClast of YH4808
时间窗: 18 points up to Day 3
Cmax of YH4808
时间窗: 18 points up to Day 2 or Day 3
次要结局
- AUCinf of YH4808(18 points up to Day 3)
- Tmax of Diclofenac(16 points up to Day 2)
- Metabolic ratio(18 points up to Day 3)
- AUCinf of Diclofenac(16points up to Day 2)
- t1/2 of Diclofenac(16 points up to Day 2)
- Tmax of YH4808(18 points up to Day 3)
- t1/2 of YH4808(18 points up to Day 3)
研究者
研究点 (1)
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