The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

NCT01549743 | Completed Phase 1

• 1 other identifier: HL-CER-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Celecoxib

EXPERIMENTAL

Drug: Celecoxib

Rebamipide

EXPERIMENTAL

Drug: Rebamipide

Celecoxib plus Rebamipide

EXPERIMENTAL

Drug: Celecoxib plus Rebamipide

Interventions

Celecoxib DRUG

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

Celecoxib

Rebamipide DRUG

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

Rebamipide

Celecoxib plus Rebamipide DRUG

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

Celecoxib plus Rebamipide

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight ae least 50kg and BMI(body mass index) within the range of 18 to 27kg/m2
• Agreement with written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

The Korea Univertisy Anam Hospital

Seoul, 136-705, South Korea

Location

MeSH Terms

Interventions

Celecoxib; rebamipide

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ji Young Park, Ph.D.

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: May 9, 2012
• Primary Completion: June 13, 2012
• Study Completion: June 13, 2012
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

KR (1)