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The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

Sponsor
Hanlim Pharm. Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01549743
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
1.1
Actual Duration (Months)
26.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Jun 13, 2012
Actual Study Completion Date :
Jun 13, 2012

Arms and Interventions

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"

Outcome Measures

Primary Outcome Measures

  1. Cmax,ss, Cmin,ss, Tmax,ss, Cav,ss, AUCĪ„, DOF(= (Cmax-Cmin)/Cav), Swing [Day1(0hr), Day2 (0hr), Day3 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hr)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01549743
Other Study ID Numbers:
  • HL-CER-101
First Posted:
Mar 9, 2012
Last Update Posted:
Aug 17, 2018
Last Verified:
Aug 1, 2018
Additional relevant MeSH terms:
Celecoxib
Rebamipide

Study Results

No Results Posted as of Aug 17, 2018