A randomized, open-label, fed, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers
To healthy subjects of 52, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
single oral administration under fed condition
single oral administration under fed condition
Chonbuk National University Hospital
Jeonju, South Korea
RECRUITINGAUCt of Carvedilol
Area under the plasma concentration of Carvedilol verses time curve from time zero to time of last quantifiable concentration
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Cmax of Carvedilol
Maximum plasma concentration of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
AUCinf of Carvedilol
Area under the plasma concentration of Carvedilol versus time curve from time zero to time infinity
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Tmax of Carvedilol
Time to maximum concentration of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
t1/2 of Carvedilol
Terminal elimination half-life of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
CL/F of Carvedilol
Total body clearance of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Vd/F of Carvedilol
Apparent volume of distribution of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.