This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers. Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.
In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64. In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
White colored oval three-layer tablet
White and pink colored oval two-layer tablet
Chonbuk National University Hospital
Jeonju, Jeollanam-do, South Korea
AUClast of Telmisartan/amlodipine/chlorthalidone
AUClast
Time frame: 0-168 hrs
Cmax of Telmisartan/amlodipine/chlorthalidone
Cmax
Time frame: 0-168 hrs
AUCinf of Telmisartan/amlodipine/chlorthalidone
AUCinf
Time frame: 0-168 hrs
Tmax of Telmisartan/amlodipine/chlorthalidone
Tmax
Time frame: 0-168 hrs
t1/2 of Telmisartan/amlodipine/chlorthalidone
t1/2
Time frame: 0-168 hrs
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