Pharmacokinetic drug interaction between celecoxib and rebamipide

Clinical trial to assess the pharmacokinetic interaction between celecoxib and rebamipide in healthy male volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000381

Enrollment

Registered

2012-03-12

Start date

2012-05-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : A: Celecoxib - Celecoxib 200mg will be administered orally twice a day for 3 days B: Rebamipide - Rebamipide 100mg will be administered orally three times a day for 3 days C: Celecoxib plus Reb

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic Interaction between celecoxib and rebamipide	—

Secondary

Measure	Time frame
Safety	—

Countries

Korea, Republic of

Contacts

Public ContactKyoung-Ah Kim

Korea University Anam Hospital

Outcome results