Drug-Drug Interaction Study of CG-651 in Healthy Volunteer

Study Overview
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Brief Summary
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This is randomized , open-label, multiple-dose, parallel study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of CG-651 in healthy volunteers.

Detailed Description
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Total of 39 health volunteers will be randomized to receive either of Group A,B or C. (13 subjects each) [Group A] Pregabalin+ Polmacoxib. [Group B] Polmacoxib [Group C] Pregabalin

Official Title
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A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of CG-651 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Polmacoxib
* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Adequate Biochemistry, Urinalysis, Serology and so on. Subject who understand the objective, method of the study and the characteristics of investigational drug and expected adverse events and provide written informed consent prior to study participation. Negative pregnancy test (hCG) and agree to contraception during the trial. Key Exclusion Criteria: History of hypersensitivity to investigational products. History of hypersensitivity or allergic reaction to sulfonamide. Patients with a history of asthma, acute rhinitis, non specific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti-inflammatory analgesics(including COX-2 inhibitors) Any other reason or situations that the investigator decides the patient is not eligible to participate the clinical trial.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A: Pregabalin + Polmacoxib Group B: Polmacoxib Group C: Pregabalin
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Pregabalin + Polmacoxib | Drug: Polmacoxib<br>* Polmacoxib<br>Drug: Pregabalin<br>* Pregabalin<br>|
| Active Comparator: Group B<br>Polmacoxib | Drug: Polmacoxib<br>* Polmacoxib<br>|
| Active Comparator: Group C<br>Pregabalin | Drug: Pregabalin<br>* Pregabalin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of polmacoxib and pregabalin | Maximum Observed Plasma Concentration | upto 4 weeks | 
| AUC of polmacoxib and pregabalin | Area Under the Concentration-Time Curve | upto 4 weeks | 
| The Number of Participants Who Experienced Adverse events (AEs) | A non-serious adverse event is any untoward medical occurrence. A serious adverse event is any adverse event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. | upto 4 weeks |