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A randomized, open-label, single-dose, crossover study
This clinical trial is conducted with a randomized, open-label, single-dose, and cross over study designs. Investigators will compare the pharmacokinetic parameters of test drug(single oral dose, single administration) with pharmacokinetic parameters of comparator 1 and 2(combined administration, single oral dose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDDO-1614 | Experimental | Bazedoxifene + Cholecalciferol combination drug |
|
| Bazedoxifene + Cholecalciferol | Active Comparator | Co-administration of Bazedoxifene and Cholecalciferol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDDO-1614 | Combination Product |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bio-Equivalence between test drug and comparators | To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614 | Day 1 ~ Day 27 |
| Measure | Description | Time Frame |
|---|---|---|
| Bazedoxifene 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 |
| Cholecalciferol Pharmacokinetic Assessment |
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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 ≤ 100mm Hg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
Those who have a history of drug or who have a positive urine drug test
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| 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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| Bazedoxifene / Cholecalciferol | Drug | Co- Administration of Bazedoxifene and Cholecalciferol |
|
Maximum 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |