KCT0000695已完成未知
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
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Yuhan
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 55(Year)（—）
- 性别
- All
入选标准
- •1. Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
- •2. Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
- •3. Subject who shows negative reaction of UBT(Urea Breath Test)
- •4. 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
- •5. Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
- •6. 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
- •1. Subject who is hypersensitive to components contained in YH4808 or this drug
- •2. 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
- •3. 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)
- •4. Sitting blood pressure meeting the following criteria at screening:
- •150 = systolic blood pressure =100 (mmHg) and
- •100 = diastolic blood pressure = 60 (mmHg) amd
- •5. Subject who has AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit at the time of screening
- •6. Subject who has history of drug abuse or shown positive reaction of drug abuse in urine test at the time of screening
- •7. Subject who participated in any other clinical trials within two months prior to the first administration of Investigational Product
- •8. Subject who donated whole blood within 2 months prior to the first administration of Investigational Product, or donated blood components or received transfusion within 1 month prior to the first administration of Investigational Product
- •9. Subject who drink continuously (over 3 units/day, 1 unit = 10 g of pure alcohol) or who cannot quit drinking while hospitalized
- •10.Subject who is judged to be ineligible 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)
研究者
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