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The purpose of this study is to learn about the effect of raloxifene on how the body absorbs and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene |
|
| Group B | Experimental | A → C → B |
|
| Group C | Experimental | B → A → C |
|
| Group D | Experimental | B → C → A |
|
| Group E | Experimental | C → A → B |
|
| Group F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve(AUCt) of raloxifene | 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours | |
| Peak plasma concentration(Cmax) of raloxifene | 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours | |
| AUCt,corr of cholecalciferol | -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours | |
| Cmax,corr of cholecalciferol | -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungbook National University Hospital | Jung-gu | Daegu | 41940 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34984851 | Derived | Lee HW, Kang WY, Jung W, Gwon MR, Cho K, Lee B, Seong SJ, Yoon YR. Pharmacokinetic Drug Interaction Between Raloxifene and Cholecalciferol in Healthy Volunteers. Clin Pharmacol Drug Dev. 2022 May;11(5):623-631. doi: 10.1002/cpdd.1062. Epub 2022 Jan 4. |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D020849 | Raloxifene Hydrochloride |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Experimental |
C → B → A |
|
| Raloxifene |
| Drug |
|
| Cholecalciferol and Raloxifene co-administration | Drug |
|
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D013629 | Tamoxifen |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |