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Primary objective : To investigate pharmacokinetics after concomitant administration of valsartan and rosuvastatin compared to single administration of valsartan or rosuvastatin in healthy male volunteers
Secondary objective : To investigate safety profiles after the administration of valsartan or rosuvastatin alone and concomitant administration of valsartan and rosuvastatin in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan 160mg, Rosuvastatin 20mg | Experimental | Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 7 days. |
|
| Rosuvastatin 20mg | Experimental | Rosuvastatin 20mg is administered daily by mouth once a day for 7 days. |
|
| Valsartan 160mg | Experimental | Valsartan 160mg is administered daily by mouth once a day for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R) | Drug | Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of valsartan and rosuvastatin | Cmax,ss and AUCÏ„,ss of valsartan and rosuvastatin | 0h (pre-dosing on 6d, 20d, 34d) and 0h (pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 48h, and 72h (on 7d, 21d, 35d). Day 1 0h (only in period 1) |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of valsartan and rosuvastatin |
| 0h (pre-dosing on 6d, 20d, 34d) and 0h (pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 48h, and 72h (on 7d, 21d, 35d). Day 1 0h (only in period 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety |
| -1d and 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 10d of Period 1, 2, 3 and 42±2d |
Inclusion Criteria:
Healthy male of 20 to 45 years of age at screening
19 kg/m2 ≤ BMI≤ 27 kg/m2 at screening
90 mmHg ≤SBP<140 mmHg and 60 mmHg ≤DBP<90 mmHg at sitting position at screening
At screening
A subject who is able to understand the study, to participate whole periods of the study and to provide written informed consent voluntarily after being fully informed of the study objectives, procedures and study drug
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Wook Ko, Professor | Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Samsung Medical Center | Seoul | South Korea |
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| Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R) | Drug | Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug |
|
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| Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V) | Drug | Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug |
|
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| Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V) | Drug | Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug |
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| Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R) | Drug | Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug |
|
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| Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R) | Drug | Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug |
|
|
| 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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