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A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.
Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR group | Experimental | CKD-391 and combination dose of Atrovastatin and Ezetimibe in order |
|
| RT group | Experimental | combination dose of Atrovastatin and Ezetimibe and CKD-391 in order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-391 | Drug | Investigational product is prescribed to all of randomized subjects for two times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | up to 96 hours post dose | |
| Cmax | up to 96 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | up to 96 hours post dose | |
| T1/2 | up to 96 hours post dose | |
| AUCinf |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Choon Ok Kim, Ph.D | Severance Hospital | Principal Investigator |
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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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| Atrovastatin and Ezetimibe combination therapy | Drug | Investigational products are prescribed to all of radomized subjects for two times. |
|
| up to 96 hours post dose |
| Adverse events | up to 24days post dose |