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The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519.
A randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-519 tablet 100mg | Experimental | CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab) Period 1: CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal |
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| CKD-519 tablet 200mg | Experimental | CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal |
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| CKD-519 soft capsule 100mg | Experimental | CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap) Period 1:CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal |
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| CKD-519 soft capsule 200mg | Experimental | CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-519 100mg | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax of CKD-519 | 0(predose)~168 | |
| AUClast of CKD-519 | 0(predose)~168 | |
| Tmax of CKD-519 | 0(predose)~168 | |
| AUCinf of CKD-519 | 0(predose)~168 | |
| T1/2 of CKD-519 | 0(predose)~168 | |
| CL/F of CKD-519 | 0(predose)~168 | |
| Vd/F of CKD-519 | 0(predose)~168 |
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of CETP(Cholesteryl ester transfer protein) Activity | 0(predose)~168 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Young Park, 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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| CKD-519 200mg |
| Drug |
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| CKD-519 100mg | Drug |
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| CKD-519 200mg | Drug |
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