The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: Celecoxib; Drug: Rebamipide; Drug: Celecoxib plus Rebamipide

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 136-705
    • The Korea Univertisy Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rebamipide	Drug: Rebamipide; Rebamipide 100mg will be administered orally three times a day for 3 days
EXPERIMENTAL: Celecoxib	Drug: Celecoxib; Celecoxib 200mg will be administered orally twice a day for 3 days
EXPERIMENTAL: Celecoxib plus Rebamipide	Drug: Celecoxib plus Rebamipide; Celecoxib plus Rebamipide same way as "arm: celecoxib" and "arm: rebamipide"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax,ss, Cmin,ss, Tmax,ss, Cav,ss, AUCτ, DOF(= (Cmax-Cmin)/Cav), Swing	Day1(0hr), Day2 (0hr), Day3 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hr)

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2012
• Primary Completion (ACTUAL): June 13, 2012
• Study Completion (ACTUAL): June 13, 2012

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (ESTIMATE): March 9, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gastrointestinal Agents; Protective Agents; Cyclooxygenase 2 Inhibitors; Anti-Ulcer Agents; Antioxidants; Celecoxib; Rebamipide
• Other Study ID Numbers: HL-CER-101