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Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215 and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Period 1: Bazedoxifene 20 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg |
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| Group B | Active Comparator | Period 1: Bazedoxifene 20 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Cholecalciferol granule 10 mg |
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| Group C | Active Comparator | Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg |
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| Group D | Active Comparator | Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg |
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| Group E | Active Comparator | Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment B | Drug | Bazedoxifene 20 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve(AUCt) of Bazedoxifene | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h | |
| Area under the plasma concentration versus time curve(AUCt) of Cholecalciferol | -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h | |
| Peak plasma concentration(Cmax) of Bazedoxifene | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h | |
| Peak plasma concentration(Cmax) of Cholecalciferol | -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Park | Dong-A University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| C447119 | bazedoxifene |
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| Group F | Active Comparator | Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Cholecalciferol granule 10 mg |
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| Treatment C | Drug | Cholecalciferol granule 10 mg |
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| Treatment BC | Drug | Bazedoxifene 20 mg, Cholecalciferol granule 10 mg |
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