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A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT group | Experimental | combination dose of Raloxifene and Cholecaliferol and DP-R213 in order |
|
| TR group | Experimental | combination dose of Raloxifene and Cholecaliferol and DP-R213 in order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DP-R213 | Drug | Investigational product is prescribed to all of randomized subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | up to 96 hours post dose | |
| Peak Plasma Concentration (Cmax) | up to 96 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36247744 | Derived | Lee HW, Kang WY, Gwon MR, Choi EJ, Kim EH, Cho K, Lee B, Seong SJ, Yoon YR. A randomized, open-label, single-dose, two-way crossover study to assess the pharmacokinetics between two tablets of fixed-dose combination formulation with raloxifene and cholecalciferol and concomitant administration of each agents in healthy male volunteers. Transl Clin Pharmacol. 2022 Sep;30(3):136-144. doi: 10.12793/tcp.2022.30.e13. Epub 2022 Sep 15. |
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| ID | Term |
|---|---|
| D020849 | Raloxifene Hydrochloride |
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Raloxifene | Drug | Investigational product is prescribed to all of randomized subjects |
|
| Cholecaliferol | Drug | Investigational product is prescribed to all of randomized subjects |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |