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The objective of this study is to compare pharmacokinetics after single oral administration of rosuvastatin and valsartan each separately versus coadministration of rosuvastatin and valsartan in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
| |
| Sequence 2 | Experimental |
| |
| Sequence 3 | Experimental |
| |
| Sequence 4 | Experimental |
| |
| Sequence 5 | Experimental |
| |
| Sequence 6 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin+Valsartan (Sequence 1) | Drug | Period 1(A) Period 2(B) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss of valsartan | 18 points up to Day 4 | |
| AUCt,ss of valsartan | 18 points up to Day 4 | |
| Cmax,ss of rosuvastatin | 18 points up to Day 4 | |
| AUCt,ss of rosuvastatin | 18 points up to Day 4 | |
| t1/2 of rosuvastatin | 18 points up to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax,ss of valsartan | 18 points up to Day 4 | |
| t1/2 of valsartan | 18 points up to Day 4 | |
| Cmin,ss of valsartan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woo-Seung Huh, MD, PhD. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuhan Corporation | Seoul | South Korea |
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| Rosuvastatin+Valsartan (Sequence 2) | Drug | Period 1(C) Period 2(A) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days) |
|
| Rosuvastatin+Valsartan (Sequence 3) | Drug | Period 1(B) Period 2(C) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days) |
|
| Rosuvastatin+Valsartan (Sequence 4) | Drug | Period 1(C) Period 2(B) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days) |
|
| Rosuvastatin+Valsartan (Sequence 5) | Drug | Period 1(B) Period 2(A) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days) |
|
| Rosuvastatin+Valsartan (Sequence 6) | Drug | Period 1(A) Period 2(C) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days) |
|
| 18 points up to Day 4 |
| Tmax,ss of rosuvastatin | 18 points up to Day 4 |
| Cmin,ss of rosuvastatin | 18 points up to Day 4 |
| t1/2 of rosuvastatin | 18 points up to Day 4 |
| Cmax,ss of N-desmetyl rosuvastatin | 18 points up to Day 4 |
| AUCt,ss of N-desmetyl rosuvastatin | 18 points up to Day 4 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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