ClinicalTrials.gov
ClinicalTrials.gov Menu

The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01549743
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: Celecoxib Drug: Rebamipide Drug: Celecoxib plus Rebamipide Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Trial to Assess the Pharmacokinetic Interaction Between Celecoxib and Rebamipide in Healthy Male Volunteers
Actual Study Start Date : May 9, 2012
Actual Primary Completion Date : June 13, 2012
Actual Study Completion Date : June 13, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Celecoxib

Arm Intervention/treatment
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"




Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549743


Locations
Korea, Republic of
The Korea Univertisy Anam Hospital
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
Principal Investigator: Ji Young Park, Ph.D. Korea University Anam Hospital

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01549743     History of Changes
Other Study ID Numbers: HL-CER-101
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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