A phase 1 clinical trail to evaluate the safety and pharmacokinetic characteristic after administration of fixed-dose combination or loose combination of HUG186 in healthy adult male or menopausal female volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)
Huons
Gyeonggi-do, Seongnam-si, South Korea
AUC0-t of Bazedoxifene
Area under the curve(AUCt) of Bazedoxifene
Time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
Cmax of Bazedoxifene
Maximum observed concentration(Cmax) of Bazedoxifene
Time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
AUC0-t of Cholecalciferol
Area under the curve(AUCt) of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Cmax of Cholecalciferol
Maximum observed concentration(Cmax) of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Tmax of Bazedoxifene
Tmax of Bazedoxifene
Time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
AUCinf of Bazedoxifene
AUCinf of Bazedoxifene
Time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
t1/2 of Bazedoxifene
t1/2 of Bazedoxifene
Time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
Tmax of Cholecalciferol
Tmax of Cholecalciferol
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Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
AUCinf of Cholecalciferol
AUCinf of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
t1/2 of Cholecalciferol
t1/2 of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)