A Phase 1 interventional study of HUG186-B and HUG186-D and HUG186 in Osteoporosis, Postmenopausal, sponsored by Huons Co., Ltd.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-23.
Sponsored by Huons Co., Ltd. · Phase 1, Interventional, and Treatment
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
Men, age≥19 years of age, Postmenopausal women are eligible. Postmenopausal is defined as any of the following:
Exclusion Criteria:
Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
Drug: HUG186-B and HUG186-D
Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)
Drug: HUG186
Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)
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
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)
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Huons Co., Ltd.