To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg
Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg
Korea University Anam Hospital
Seoul, South Korea
Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
Half life (t1/2) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
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