This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of amlodipine and valsartan (reference formulation) for single dose in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
A single oral dose of a combination tablet of amlodipine orotate 10mg and valsartan 160mg
A single oral dose of a combination tablet of amlodipine besylate 10mg and valsartan 160mg
Severance Hospital
Seoul, South Korea
Profile of Pharmacokinetics
Cmax, Area Under Curve(0 to the last sampling time)
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose
Profile of Pharmacokinetics
Tmax, Area Under Curve(0 to infinity), T\_1/2
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose
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