The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

This study is not yet open for participant recruitment.
Verified March 2012 by Hanlim Pharm. Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01549743
First received: March 7, 2012
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Healthy Male Volunteers
Drug: Celecoxib
Drug: Rebamipide
Drug: Celecoxib plus Rebamipide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Clinical Trial to Assess the Pharmacokinetic Interaction Between Celecoxib and Rebamipide in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Hanlim Pharm. Co., Ltd.:

Primary Outcome Measures:
  • Cmax,ss, Cmin,ss, Tmax,ss, Cav,ss, AUCτ, DOF(= (Cmax-Cmin)/Cav), Swing [ Time Frame: Day1(0hr), Day2 (0hr), Day3 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hr) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celecoxib Drug: Celecoxib
Celecoxib 200mg will be administered orally twice a day for 3 days
Experimental: Rebamipide Drug: Rebamipide
Rebamipide 100mg will be administered orally three times a day for 3 days
Experimental: Celecoxib plus Rebamipide Drug: Celecoxib plus Rebamipide
Celecoxib plus Rebamipide same way as "arm: celecoxib" and "arm: rebamipide"

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549743

Contacts
Contact: Seulah Kim 82-2-3489-6165 sseul@hanlim.com

Locations
Korea, Republic of
The Korea Univertisy Anam Hospital Not yet recruiting
Seoul, Korea, Republic of, 136-705
Contact: Ji Young Park, Ph.D.     82-2-920-6448        
Principal Investigator: Ji Young Park, Ph.D.            
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
Principal Investigator: Ji Young Park, Ph.D. Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01549743     History of Changes
Other Study ID Numbers: HL-CER-101
Study First Received: March 7, 2012
Last Updated: March 8, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Rebamipide
Celecoxib
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013