A Drug-drug Interaction Study of DP-R213

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-03-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group A

A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Cholecalciferol and Raloxifene co-administration

Intervention Type DRUG

Group B

A → C → B

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Cholecalciferol and Raloxifene co-administration

Intervention Type DRUG

Group C

B → A → C

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Cholecalciferol and Raloxifene co-administration

Intervention Type DRUG

Group D

B → C → A

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Cholecalciferol and Raloxifene co-administration

Intervention Type DRUG

Group E

C → A → B

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Cholecalciferol and Raloxifene co-administration

Intervention Type DRUG

Group F

C → B → A

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Cholecalciferol and Raloxifene co-administration

Intervention Type DRUG

Interventions

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Cholecalciferol

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Cholecalciferol and Raloxifene co-administration

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes