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Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bazedoxifene 20mg | Active Comparator | Subjects will take bazedoxifene 1 Tablet. |
|
| Cholecalciferol | Active Comparator | Subjects will take Cholecalciferol 2 Tablets. |
|
| Bazedoxifene 20mg and Cholecalciferol | Experimental | Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bazedoxifene 20 mg | Drug | To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug-Drug Interaction | To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol. | Day 1~Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Assessment | Bazedoxifene Maximum Plasma Concentration | 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours |
| Pharmacokinetic Assessment | Bazedoxifene Area Under Curve |
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Inclusion Criteria:
Exclusion Criteria:
Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
Any person who shows any of the following results in the screening test
Those who show signs of hypotension (systolic blood pressure ≤ 100mmHg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
Those who have a history of drug abuse or who have a positive urine drug test
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Heon Cho | Inha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Junggu | Incheon | 22332 | South Korea |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C447119 | bazedoxifene |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Cholecalciferol | Drug | To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time. |
|
| Bazedoxifene 20mg and Cholecalciferol | Drug | For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once. |
|
| 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours |
| Pharmacokinetic Assessment | Maximun Plasma Concentration after correction of basal concentration of Cholecalciferol | Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour |
| Pharmacokinetic Assessment | Area Under Curve after correction of basal concentration of Cholecalciferol | Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |