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An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combination of AK-R215 in healthy adult male or menopausal female volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | Experimental | AK-R215, test drug |
|
| B group | Active Comparator | reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK-R215 | Drug | Investigational product is prescribed to all ofrandomized subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h | |
| Cmax | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h | |
| AUCinf, | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Busan | South Korea |
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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 20 mg | Drug | Investigational product is prescribed to all of randomized subjects |
|
| Cholecalciferol 800IU | Drug | Investigational product is prescribed to all of randomized subjects |
|
| T1/2 |
| 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |