The Pharmacokinetic Interaction Between Celecoxib and Rebamipide
This study is not yet open for participant recruitment.
Verified March 2012 by Hanlim Pharm. Co., Ltd.
Sponsor:
Hanlim Pharm. Co., Ltd.
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01549743
First received: March 7, 2012
Last updated: March 8, 2012
Last verified: March 2012
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Purpose
This clinical trial aims to assess the pharmacokinetic interaction between celecoxib and rebamipide in healthy male subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Male Volunteers |
Drug: Celecoxib Drug: Rebamipide Drug: Celecoxib plus Rebamipide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Clinical Trial to Assess the Pharmacokinetic Interaction Between Celecoxib and Rebamipide in Healthy Male Volunteers |
Resource links provided by NLM:
MedlinePlus related topics:
Drug Reactions
Drug Information available for:
Celecoxib
U.S. FDA Resources
Further study details as provided by Hanlim Pharm. Co., Ltd.:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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"
|
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549743
Contacts
| Contact: Seulah Kim | 82-2-3489-6165 | sseul@hanlim.com |
Locations
| Korea, Republic of | |
| The Korea Univertisy Anam Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 136-705 | |
| Contact: Ji Young Park, Ph.D. 82-2-920-6448 | |
| Principal Investigator: Ji Young Park, Ph.D. | |
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
| Principal Investigator: | Ji Young Park, Ph.D. | Korea University Anam Hospital |
More Information
No publications provided
| Responsible Party: | Hanlim Pharm. Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01549743 History of Changes |
| Other Study ID Numbers: | HL-CER-101 |
| Study First Received: | March 7, 2012 |
| Last Updated: | March 8, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rebamipide Celecoxib Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Enzyme Inhibitors |
Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013