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Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.
Open-label, Randomized, 3-period, 6-sequence, crossover study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) |
|
| Group 2 | Experimental | B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) |
|
| Group 3 | Experimental | C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) |
|
| Group 4 | Experimental | A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) |
|
| Group 5 | Experimental | B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-519 50mg 2Tabs. | Drug | after taking Standard meal, CKD-519 50mg 2Tabs. administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | |
| Tmax of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | |
| AUClast of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | |
| AUC0-∞ of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | |
| t1/2 of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | |
| CL/F of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | |
| Vd/F of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | |
| Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h | |
| Tmax of CKD-519 CETP Activity | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h | |
| AUEC of CKD-519 CETP Activity | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Young Kim, MD, PhD | Korea University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea university medical center | Seoul | Sungbuk-gu | 136-705 | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000620552 | CKD-519 |
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| Group 6 | Experimental | C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) |
|
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| CKD-519 100mg 1Tab. | Drug | after taking Standard meal, CKD-519 100mg 1Tab. administration. |
|
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| CKD-519 100mg 1Cap. | Drug | after taking Standard meal, CKD-519 100mg 1Cap. administration. |
|
|
| EC50(half maximal effective concentration ) of CKD-519 CETP Activity | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h |