A Drug-drug Interaction Study of DP-R213

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label, Single-dose, 3-period, 6-sequence Crossover Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of Raloxifene, Cholecalciferol in Healthy Korean Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Cholecalciferol
* Drug: Raloxifene
* Drug: Cholecalciferol and Raloxifene co-administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteer, age above 19 The result of Ideal Body Weight(IBW) is not less than -20%, no more than +20% Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial. Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment in completion of this clinical study Treatment history of other drugs within last 10 days

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene | Drug: Cholecalciferol<br> <br> Drug: Raloxifene<br> <br> Drug: Cholecalciferol and Raloxifene co-administration<br> <br> |
| Experimental: Group B<br>A → C → B | Drug: Cholecalciferol<br> <br> Drug: Raloxifene<br> <br> Drug: Cholecalciferol and Raloxifene co-administration<br> <br> |
| Experimental: Group C<br>B → A → C | Drug: Cholecalciferol<br> <br> Drug: Raloxifene<br> <br> Drug: Cholecalciferol and Raloxifene co-administration<br> <br> |
| Experimental: Group D<br>B → C → A | Drug: Cholecalciferol<br> <br> Drug: Raloxifene<br> <br> Drug: Cholecalciferol and Raloxifene co-administration<br> <br> |
| Experimental: Group E<br>C → A → B | Drug: Cholecalciferol<br> <br> Drug: Raloxifene<br> <br> Drug: Cholecalciferol and Raloxifene co-administration<br> <br> |
| Experimental: Group F<br>C → B → A | Drug: Cholecalciferol<br> <br> Drug: Raloxifene<br> <br> Drug: Cholecalciferol and Raloxifene co-administration<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |