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Completed

NCT Number: NCT01549743

The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

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

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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The Korea Univertisy Anam Hospital

Seoul, 136-705, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

Celecoxib 200mg will be administered orally twice a day for 3 days

rebamipide

Drug

Rebamipide 100mg will be administered orally three times a day for 3 days

Celecoxib plus Rebamipide

Drug

Celecoxib plus Rebamipide same way as "arm: celecoxib" and "arm: rebamipide"

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study title

Clinical Trial to Assess the Pharmacokinetic Interaction Between Celecoxib and Rebamipide in Healthy Male Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2012
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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