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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
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phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with co-administration of D090 and D337 in healthy adult volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T |
|
| Group B | Experimental | R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T |
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| Group C | Experimental | T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R |
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| Group D | Experimental | T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-391 10/10mg | Drug | Drug T: CKD-391 10/10mg(Other Name: Test Drug) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax 1) Atorvastatin, unconjugated ezetimibe(Cmax) | 0~72hours |
| AUCt | To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt 1) Atorvastatin, unconjugated ezetimibe(AUCt) | 0~72hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jae-Yong Chung | Gyeonggi-do | Seongnam-si | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| D090, D337 | Drug | D090 and D337 co-administration(Other Name: Reference drug) |
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