To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
42
Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)
Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg
Samsung Medical Center
Seoul, South Korea
Cmax of amlodipine
Time frame: Up to 72 hours
Cmax of valsartan
Time frame: Up to 72 hours
Cmax of atorvastatin
Time frame: Up to 72 hours
AUCt of amlodipine
Time frame: Up to 72 hours
AUCt of valsartan
Time frame: Up to 72 hours
AUCt of atorvastatin
Time frame: Up to 72 hours
tmax of amlodipine
Time frame: Up to 72 hours
tmax of valsartan
Time frame: Up to 72 hours
tmax of atorvastatin
Time frame: Up to 72 hours
t1/2 of atorvastatin
Time frame: Up to 72 hours
t1/2 of amlodipine
Time frame: Up to 72 hours
t1/2 of valsartan
Time frame: Up to 72 hours
AUCinf of amlodipine
Time frame: Up to 72 hours
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AUCinf of valsartan
Time frame: Up to 72 hours
AUCinf of atorvastatin
Time frame: Up to 72 hours
AUCt of 2-OH atorvastatin
Time frame: Up to 72 hours
Cmax of 2-OH atorvastatin
Time frame: Up to 72 hours
tmax of 2-OH atorvastatin
Time frame: Up to 72 hours
t1/2 of 2-OH atorvastatin
Time frame: Up to 72 hours
AUCinf of 2-OH atorvastatin
Time frame: Up to 72 hours