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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1\~Day5
Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9\~Day21
Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22\~Day26
Korea University Anam Hospital
Seoul, South Korea
Pharmacokinetics (Area under the plasma concentration versus time curve (AUCτ))
At steady state after multiple administration of CKD-519, Rosuvastatin
Time frame: 0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26
Pharmacokinetics (Peak plasma Concentration (Cmax,ss))
At steady state after multiple administration of CKD-519, Rosuvastatin
Time frame: 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))
At steady state after multiple administration of CKD-519, Rosuvastatin
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0(predose)~24 hours at Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacodynamics (CETP Concentration)
At steady state after multiple administration of CKD-519, Rosuvastatin
Time frame: 0(predose)~24 hours at Day9, Day19, Day22, Day26
Pharmacodynamics (Lipid profiles)
Time frame: simultaneous with laboratory test at Day1, Day6, Day9, Day20, Day22, Day27