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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Pregabalin + Polmacoxib |
|
| Group B | Active Comparator | Polmacoxib |
|
| Group C | Active Comparator | Pregabalin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polmacoxib | Drug | Polmacoxib |
| |
| Pregabalin |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| C000599293 | CG100649 |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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None (open label)
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| Drug |
Pregabalin |
|
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |