Clinical trial NCT01549743: The Pharmacokinetic Interaction Between Celecoxib and Rebamipide
Official title: Clinical Trial to Assess the Pharmacokinetic Interaction Between Celecoxib and Rebamipide in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


Eligibility 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

Primary outcomes:
measure: Cmax,ss, Cmin,ss, Tmax,ss, Cav,ss, AUCτ, DOF(= (Cmax-Cmin)/Cav), Swing
timeFrame: Day1(0hr), Day2 (0hr), Day3 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hr)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Korea Univertisy Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Ji Young Park, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: