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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.
To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Livasupril Cap.160/2mg | Experimental |
|
|
| Lipilfen cap.160mg, Livaro tab. 2mg | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livasupril Cap.160/2mg | Drug | Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast(area under the curve) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | |
| Cmax(maximum concentration) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | |
| AUClast(area under the curve) of pitavastatin | Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | |
| Cmax(maximum concentration) of pitavastatin | Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf(area under the curve) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | |
| Tmax(time to Maximum Plasma Concentration) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Young-Ran Yoon, M.D., Ph.D. | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | 700-721 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lipilfen cap. 160mg | Drug | Micronized fenofibrate 160mg |
|
| Livaro tab. 2mg | Drug | Pitavastatin Ca 2mg |
|
| t1/2(half life) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) |
| AUCinf(area under the curve) of pitavastatin | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) |
| Tmax(time to Maximum Plasma Concentration) of pitavastatin | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) |
| t1/2(half life) of pitavastatin | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) |
| Number of participants with adverse events | Participants will be followed for the duration of hospital stay, and expected period for maximum 7 days from the discharge |