The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

Hanlim Pharm

Status and phase

Completed

Phase 1

Conditions

Healthy Male Volunteers

Treatments

Drug: Rebamipide

Drug: Celecoxib plus Rebamipide

Drug: Celecoxib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01549743

HL-CER-101

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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