The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: Celecoxib; Drug: Rebamipide; Drug: Celecoxib plus Rebamipide

• Registration Number: NCT01549743
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-09
• Study Start: 2012-05-09
• Primary Completion: 2012-06-13
• Study Completion: 2012-06-13
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Celecoxib	Celecoxib	-
Rebamipide	Rebamipide	-
Celecoxib plus Rebamipide	Celecoxib plus Rebamipide	-

Primary Outcome Measures

Name	Time	Method
Cmax,ss, Cmin,ss, Tmax,ss, Cav,ss, AUCτ, DOF(= (Cmax-Cmin)/Cav), Swing	Day1(0hr), Day2 (0hr), Day3 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hr)

Trial Locations

Locations (1)

The Korea Univertisy Anam Hospital; 🇰🇷 Seoul, Korea, Republic of