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To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ID140009 | Experimental |
| |
| ID1803+ID1805 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID140009 | Combination Product | Combination Product: ID140009 Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg/ Amlodipine 10mg/ Valsartan 160mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) | Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt | 0~72hr |
| Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) | Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax | 0~72hr |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt (Free Ezetimibe) | Free Ezetimibe: AUCt | 0~72hr |
| Cmax (Free Ezetimibe) | Free Ezetimib: Cmax | 0~72hr |
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Inclusion Criteria:
Exclusion Criteria:
• Subject with any clinically significant cardiovascular, respiratory, endocrinology, infectious disease, ophthalmology, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MinJung Kim | Contact | 025263179 | mjkim90@ildong.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H plus yangji hospital | Recruiting | Seoul | South Korea |
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| ID1803+ID1805 | Combination Product | (Amlodipine 10mg/Valsartan 160mg)+(Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg) |
|
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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