The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Hanlim Pharm. Co., Ltd..
Recruitment status was  Not yet recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014