The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects
This study is to evaluate the pharmacokinetic characteristics and safety of AD-102 compared with administration of raloxifen 60 mg + Cholecalciferol 800IU in healthy male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Raloxifene 60mg/Cholecalciferol 800IU tablet
AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet
Korea University Guro Hosptial
Seoul, South Korea
Peak Plasma Concentration (Cmax)
Cmax of Raloxifene
Time frame: pre-dose to 96 hours
Peak Plasma Concentration (Cmax)
Cmax of corrected Cholecalciferol
Time frame: pre-dose to 72 hours
Area under the curve in time plot (AUCt)
AUCt of Raloxifene
Time frame: pre-dose to 96 hours
Area under the curve in time plot (AUCt)
AUCt of corrected Cholecalciferol
Time frame: pre-dose to 72 hours
Area under the curve in time plot (AUCinf)
AUCinf of Raloxifene
Time frame: pre-dose to 96 hours
Area under the curve in time plot (AUCinf)
AUCinf of Corrected Cholecalciferol
Time frame: pre-dose to 72 hours
Time to reach Cmax
Tmax of Raloxifene
Time frame: pre-dose to 96 hours
Time to reach Cmax
Tmax of Corrected Cholecalciferol
Time frame: pre-dose to 72 hours
Effective half-life
t1/2 of Raloxifene
Time frame: pre-dose to 96 hours
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Effective half-life
t1/2 of Corrected Cholecalciferol
Time frame: pre-dose to 72 hours