KCT0001012已完成未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Yuhan
- 入组人数
- 36
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 45(Year)（—）
- 性别
- Male
入选标准
- •1. healthy male age 20 to 45 at the screening visit
- •2. over 55kg with ideal body weight (BMI +-20%)
- •3. Subject who has no congenital, chronic disease and disease symptoms in medical examination result.
- •4. Subject who is judged to be eligible according to clinical laboratory tests including hematological examination, blood chemistry examination, urine analysis.
- •5. Subject who volunteerly determined to participate in and agreed to comply with precautions after totally understand the detailed explanations about this study.
排除标准
- •1. Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, blood tumor, cardiovascular, urinary, endocrine system, immune system, musculoskeletal, otorhinolaryngeal, mental disorder, especially in gastrointestinal tract.
- •2.Subject who has history of surgical operation or diseases related to gastrointestinal symtom (e.g. crohn's disease, ulcer etc except appendectomy or simple for herina)
- •3. Subject who is hypersensitive to YH4808, diclofenac or drug containing components of rabamipide, revaprazan, NSAIDs(Nonsteroidal anti-inflammatory drugs), etc.
- •4. Other exclusions apply.
研究者
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