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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polmacoxib and Tramadol combination | Experimental | Tramadol + Polmacoxib capsule |
|
| Polmacoxib | Active Comparator | Polmacoxib |
|
| Tramadol | Active Comparator | Tramadol hydrochloride (HCl) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polmacoxib and Tramadol combination | Drug | Tramadol hydrochloride , Polmacoxib |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau of Polmacoxib and Tramadol | up to 4 weeks | |
| Cmax of Polmacoxib and Tramadol | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Polmacoxib | up to 4 weeks | |
| AUC tau of Polmacoxib | up to 4 weeks | |
| Cmax of Tramadol |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| C000599293 | CG100649 |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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Group A: Tramadol hydrochloride +Polmacoxib Group B: Polmacoxib Group C: Tramadol hydrochloride
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| Polmacoxib | Drug | Polmacoxib |
|
| Tramadol hydrochloride | Drug | Tramadol hydrochloride (HCl) |
|
|
| up to 4 weeks |
| AUCtau of Tramadol | up to 4 weeks |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |