Drug-Drug Interaction Study of CG100650 in Healthy Volunteers

Study Overview
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Brief Summary
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This is a randomized, open-label, multiple-dose, parallel, Phase 1 study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of CG100650 in healthy volunteers.

Detailed Description
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This is a randomized, open label, multiple-dose, parallel study to compare PK and to evaluate Drug-Drug Interaction of CG100650 in healthy volunteers. Total of 39 health volunteers will be randomized to receive either of Group A, B or C for 14 days (13 subjects each). [Group A] Tramadol +Polmacoxib capsule [Group B] Polmacoxib capsule [Group C] Tramadol Pharmacokinetic parameters will be evaluated as primary endpoint by changes from baseline; Safety evaluation will be carried out by conducting vital sign, laboratory test, ECG, and collecting AE, CM by different Group.

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 CG100650 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Polmacoxib and Tramadol combination
* Drug: Polmacoxib
* Drug: Tramadol hydrochloride


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or female aged ≥ 19 years and ≤ 50 years Without inborn or chronic disease and no symptoms in physical examination BMI(Body Mass Index) result ≥ 18kg/m 2 and ≤ 30kg/m2 Adequate clinical laboratory test results as evidenced by Hematology, Hemostasis, 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, nonspecific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti- inflammatory analgesics (including COX-2 inhibitors) Genetically galactose intolerance, lactose intolerance or Glucose-Galactose Malabsorption Any other reasons 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: Tramadol hydrochloride +Polmacoxib Group B: Polmacoxib Group C: Tramadol hydrochloride
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polmacoxib and Tramadol combination<br>Tramadol + Polmacoxib capsule | Drug: Polmacoxib and Tramadol combination<br>* Tramadol hydrochloride , Polmacoxib<br>|
| Active Comparator: Polmacoxib<br>Polmacoxib | Drug: Polmacoxib<br>* Polmacoxib<br>|
| Active Comparator: Tramadol<br>Tramadol hydrochloride (HCl) | Drug: Tramadol hydrochloride<br>* Tramadol hydrochloride (HCl)<br>* Other names: Tramadol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau of Polmacoxib and Tramadol |  | up to 4 weeks | 
| Cmax of Polmacoxib and Tramadol |  | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Polmacoxib |  | up to 4 weeks | 
| AUC tau of Polmacoxib |  | up to 4 weeks | 
| Cmax of Tramadol |  | up to 4 weeks | 
| AUCtau of Tramadol |  | up to 4 weeks |