The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

• Status: Completed
• Trial end date: 2012-06-13
• Target enrollment: 0
• Participant gender: Male

Summary

This clinical trial aims to assess the pharmacokinetic interaction between celecoxib and rebamipide in healthy male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Celecoxib; Rebamipide

Criteria

Inclusion Criteria:

• Body weight ae least 50kg and BMI(body mass index) within the range of 18 to 27kg/m2

• Agreement with written informed consent

Exclusion Criteria:

• 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