The Pharmacokinetic Interaction Between Celecoxib and Rebamipide
NCT ID: NCT01549743
Last Updated: 2018-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2012-05-09
2012-06-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Celecoxib
Celecoxib
Celecoxib 200mg will be administered orally twice a day for 3 days
Rebamipide
Rebamipide
Rebamipide 100mg will be administered orally three times a day for 3 days
Celecoxib plus Rebamipide
Celecoxib plus Rebamipide
Celecoxib plus Rebamipide same way as "arm: celecoxib" and "arm: rebamipide"
Interventions
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Celecoxib
Celecoxib 200mg will be administered orally twice a day for 3 days
Rebamipide
Rebamipide 100mg will be administered orally three times a day for 3 days
Celecoxib plus Rebamipide
Celecoxib plus Rebamipide same way as "arm: celecoxib" and "arm: rebamipide"
Eligibility Criteria
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Inclusion Criteria
* Agreement with written informed consent
Exclusion Criteria
* 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
20 Years
45 Years
MALE
Yes
Sponsors
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Hanlim Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ji Young Park, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Locations
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The Korea Univertisy Anam Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HL-CER-101
Identifier Type: -
Identifier Source: org_study_id
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