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| Name | Class |
|---|---|
| Yonsei University | OTHER |
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The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and CS-866 in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R | Experimental | multiple dose of Rosuvastatin 20mg |
|
| O | Experimental | multiple dose of CS-866 40mg |
|
| R+O | Experimental | multiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cresto | Drug | tablet, 20mg |
| |
| Olmetec |
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.((in case of CS-866, for 48 hours) | |
| Css,max | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.(in case of CS-866, for 48 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| AUCss,last | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours) | |
| AUCss,inf | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours) |
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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, 40mg |
|
| Cresto, Olmetec | Drug | tablet, 20mg and 40mg |
|
| Css,min | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours) |
| T1/2 | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours) |
| D013777 |
| Tetrazoles |