NCT01549743已完成1 期
Clinical Trial to Assess the Pharmacokinetic Interaction Between Celecoxib and Rebamipide in Healthy Male Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cmax,ss, Cmin,ss, Tmax,ss, Cav,ss, AUCτ, DOF(= (Cmax-Cmin)/Cav), Swing
研究概览
简要总结
This clinical trial aims to assess the pharmacokinetic interaction between celecoxib and rebamipide in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Body weight ae least 50kg and BMI(body mass index) within the range of 18 to 27kg/m2
- •Agreement with written informed consent
排除标准
- •Subject with symptoms of acute disease within 28days prior to study medication dosing
- •Subject with known for history which affect on the absorption, distribution, metabolism, excretion of drug
- •Subject with clinically significant active cardiovascular, respiratory, renal, endocrine, hematologic, gastrointestinal, neurologic, autoimmunologic disease or malignant tumor
- •Subject with unsuitable clinical test through the medical checkup(medical history, physical examination, ECG, laboratory test) within 28days prior to study medication dosing
- •Subject with any of the following findings; i. AST(sGOT) or ALT(sGPT) > 1.5 fold normal value or ii. Total bilirubin > 1.5 fold normal value
- •Subject with clinically significant allergic disease (except for mild allergic rhinitis, mild allergic dermatitis seems to be not need for medication)
- •Subject with known for hypersensitivity reaction to celecoxib, rebamipide, sulphonamide analog
- •Subject with asthma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic reaction to aspirin or any other NSAIDs(including COX-2 inhibitors)
- •Subject with hereditary disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Use of any prescription medication within 14 days prior to study medication dosing
- •Use of any medication(Over-the-counter medication, oriental medication, vitamin) within 7 days prior to study medication dosing
- •Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug
- •Subject who is not able to taking the institutional standard meal
- •Whole blood donation within 60days, component blood donation within 20days or receiving blood transfusion within 30days prior to study medication dosing
- •Participation in any clinical investigation within 60days prior to study medication dosing
- •Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day)
- •An impossible one who participate in clinical trial by investigator's decision including for reason of laboratory test result
研究组 & 干预措施
Celecoxib
Experimental
干预措施: Celecoxib (Drug)
Rebamipide
Experimental
干预措施: Rebamipide (Drug)
Celecoxib plus Rebamipide
Experimental
干预措施: Celecoxib plus Rebamipide (Drug)
结局指标
主要结局
Cmax,ss, Cmin,ss, Tmax,ss, Cav,ss, AUCτ, DOF(= (Cmax-Cmin)/Cav), Swing
时间窗: Day1(0hr), Day2 (0hr), Day3 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hr)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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