The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
PO, 1day or 22day
PO, 1day or 22day
PO, 1day or 22day
Chungnam National University Hospital
Daejeon, Jung-gu, South Korea
Cmax(Maximum Plasma Concentration) of Candesartan
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
AUCt(Area Under the Plasma Concentration-time curve) of Candesartan
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
Cmax(Maximum Plasma Concentration) of Amlodipine
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
AUCt(Area Under the Plasma Concentration-time curve) of Amlodipine
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Candesartan
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
tmax(Time to reach the maximum concentration) of Candesartan
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
t1/2β(Time for C max to drop in half) of Candesartan
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
CL/F(Clearance/Bioavailability) of Candesartan
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Amlodipine
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
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tmax(Time to reach the maximum concentration) of Amlodipine
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
t1/2β(Time for C max to drop in half) of Amlodipine
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
CL/F(Clearance/Bioavailability) of Amlodipine
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr