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The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers.
Phase 1 to evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2. Which is designed as ramdomized, oral, single dose, 2×2 crossover.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single tablet fist, fasted | Experimental | single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition |
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| FDC fist, fasted | Experimental | NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition |
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| Single tablet fist, fed | Experimental | single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition |
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| FDC fist, fed | Experimental | NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVP-2002-R1+NVP-2002-R2 | Drug | NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of plasma: Cmax | Cmax of NVP-2002-R1 and NVP-2002-R2 | 0hours - 72hours |
| Pharmacokinetics of plasma: AUCt | Area under the curve of NVP-2002-R1 and NVP-2002-R2 | 0hours - 72hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min-Gul Kim, M.D., Ph.D | Jeonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk national university hospital | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| NVP-2002 | Drug | NVP-2002 is a combination of NVP-2002-R1 and NVP-2002_R2 NVP-2002, 1 tablet, once daily |
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