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The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of combination of rosuvastatin and CS-866 and DWJ1276 alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin+Olmesartan | Active Comparator | single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg |
|
| DWJ1276 | Experimental | Single dose of DWJ1276 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cresto | Drug | tablet, rosuvastatin 20mg |
| |
| Olmetec |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | 18 time points up to 72 hours | |
| Cmax | 18 time points up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | 18 time points up to 72 hours | |
| T1/2 | 18 time points up to 72 hours | |
| %AUCextra |
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Inclusion Criteria:
Exclusion Criteria:
A subject who had any allergic history to any drug.
A subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases
History or suspicion of current drug abuse
A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication
A subject who had participated in any other clinical study within the last 2 weeks
A subject from whom over 400mL of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.
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| Name | Affiliation | Role |
|---|---|---|
| Kyungsoo Park, M.D., Ph.D. | YONSEI UNIVERSITY HEALTH SYSTEM (YUHS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System (Yuhs) | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
tablet, olmesartan medoxomil(CS-866) 40mg |
|
| DWJ1276 | Drug | tablet, Rosuvastatin 20mg and olmesartan medoxomil 40mg |
|
| 18 time points up to 72 hours |
| Tmax | 18 time points up to 72 hours |
| D013777 |
| Tetrazoles |