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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HUG186-B and HUG186-D | Active Comparator | Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU) |
|
| HUG186 | Experimental | Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HUG186-B and HUG186-D | Drug | Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU) |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t of Bazedoxifene | Area under the curve(AUCt) of Bazedoxifene | 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 | 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 | -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 | -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points) |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of Bazedoxifene | Tmax of Bazedoxifene | 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 |
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Inclusion Criteria:
Men, age≥19 years of age, Postmenopausal women are eligible. Postmenopausal is defined as any of the following:
Body weight of ≥ 55 kg, BMI 18.5 to 30.0
No morbid symptom or sign, based on physical examination, with no innate or chronic disease.
Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis) that is performed according to the characteristics of investigational drugs.
Subject that agree to apply sun cream in case of daylight exposure for more than 1hours
Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huons | Gyeonggi-do | Seongnam-si | 13486 | South Korea |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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A randomized, open-label, single-dose, two-treatment, two-sequence, two-way crossover study
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| HUG186 | Drug | Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU) |
|
| 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 | 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 | -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 | -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 | -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points) |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |