KCT0000381尚未招募未知
Clinical trial to assess the pharmacokinetic interaction between celecoxib and rebamipide in healthy male volunteers
Hanlim Pharmaceutical0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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)Body weight ae least 50kg and BMI(body mass index) within the range of 18 to 27kg/m2
- •2) Agreement with written informed consent
排除标准
- •1) Subject with symptoms of acute disease within 28days prior to study medication dosing
- •2) Subject with known for history which affect on the absorption, distribution, metabolism, excretion of drug
- •3) Subject with clinically significant active cardiovascular, respiratory, renal, endocrine, hematologic, gastrointestinal, neurologic, autoimmunologic disease or malignant tumor
- •4) Subject with unsuitable clinical test throughthe medical checkup(medical history, physical examination, ECG, laboratory test) within 28days prior to study medication dosing
- •5) 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
- •6) Subject with clinically significant allergic disease (except for mild allergic rhinitis, mild allergic dermatitis seems to be not need for medication)
- •7) Subject with known for hypersensitivity reaction to celecoxib, rebamipide, sulphoamide analog
- •8) Subject with asthma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic reaction to aspirin or any other NSAIDs(including COX-2 inhibitors)
- •9) Subject with hereditary disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •10) Use of any prescription medication within 14 days prior to study medication dosing
- •11) Use of any medication(Over-the-counter medication, oriental medication, vitamin) within 7 days prior to study medication dosing
- •12) Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug
- •13) Subject who is not able to taking the institutional standard meal
- •14) Whole blood donation within 60days, component blood donation within 20days or receiving blood transfusion within 30days prior to study medication dosing
- •15) Participation in any clinical investigation within 60days prior to study medication dosing
- •16) Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day)
- •17) An impossible one who participate in clinical trial by investigator's decision including for reason of laboratory test result
研究者
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