a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A single oral dose of 1 tablet under fasting conditions for each period
A single oral dose of 1 tablet under fasting conditions for each period
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Gachon University Gil Medical Center
Incheon, South Korea
RECRUITINGAUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
AUC0-t: Area under the concentration-time curve from time zero to time
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Cmax: Maximum plasma concentration of the drug
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
AUCinf: Area under the concentration-time curve from zero up to ∞
Time frame: 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31
Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Tmax: Time to maximum plasma concentration
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
t1/2: Terminal elimination half-life
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
CL/F: Apparent total body clearance of the drug
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Vd/F: Apparent volume of distribution
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
AUC0-t: Area under the concentration-time curve from time zero to time
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Cmax: Maximum plasma concentration of the drug
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31