Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and Olmesartan (reference formulation) for single dose in healthy volunteers
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test and reference formulations | Experimental | Test formulation and reference formulation given orally 7 days apart in a fasted state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test formulation | Drug | Single administration of a combination tablet of Rosuvastatin 20mg and Olmesartan 40mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Pharmacokinetics | Cmax, Area Under Curve (0 to last sampling time) | 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Pharmacokinetics | Tmax, Area Under Curve (0 to infinity), T_1/2 | 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23810276 | Derived | Son H, Roh H, Lee D, Chang H, Kim J, Yun C, Park K. Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects. Clin Ther. 2013 Jul;35(7):915-22. doi: 10.1016/j.clinthera.2013.05.016. Epub 2013 Jun 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Reference formulation | Drug | Co-administration of Rosuvastatin 20mg tablet and Olmesartan 40mg tablet |
|