Pharmacokinetic drug interaction between celecoxib and rebamipide
- Conditions
- Not Applicable
- Registration Number
- KCT0000381
- Lead Sponsor
- Hanlim Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic Interaction between celecoxib and rebamipide
- Secondary Outcome Measures
Name Time Method Safety