A Drug-drug Interaction Study of DP-R213

Alvogen Korea24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CholecalciferolDRUG

RaloxifeneDRUG

Cholecalciferol and Raloxifene co-administrationDRUG

Eligibility

Sex: MALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kyungbook National University Hospital

Jung-gu, Daegu, South Korea

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve(AUCt) of raloxifene

Time frame: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours

Peak plasma concentration(Cmax) of raloxifene

Time frame: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours

AUCt,corr of cholecalciferol

Time frame: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours

Cmax,corr of cholecalciferol

Time frame: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours

Data from ClinicalTrials.gov

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