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
The purpose of this study is to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.
An open-label, multiple dose, fixed-sequence, 3-period study to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin 20 mg & CKD-519 200 mg | Experimental | Period 1: Treatment A(Rosuvastatin 20 mg(20 mg X 1 tablet)) Period 2: Treatment B(CKD-519 200 mg(100 mg X 2 tablets)) Period 3: Treatment C(Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin 20 mg | Drug | Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1~Day5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Area under the plasma concentration versus time curve (AUCÏ„)) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Peak plasma Concentration (Cmax,ss)) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 |
| Pharmacokinetics (Minimum plasma Concentration (Cmin,ss)) |
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 |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C000620552 | CKD-519 |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CKD-519 200 mg | Drug | Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9~Day21 |
|
|
| Rosuvastatin 20 mg & CKD-519 200 mg | Drug | Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22~Day26 |
|
|
At steady state after multiple administration of CKD-519, Rosuvastatin |
| 0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 |
| Pharmacokinetics (Time to maximum plasma concentration (Tmax,ss)) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 |
| Pharmacokinetics (t1/2) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 |
| Pharmacodynamics (CETP activity) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose)~24 hours at Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 |
| Pharmacodynamics (CETP Concentration) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose)~24 hours at Day9, Day19, Day22, Day26 |
| Pharmacodynamics (Lipid profiles) | simultaneous with laboratory test at Day1, Day6, Day9, Day20, Day22, Day27 |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |