A Drug-drug Interaction Study of DP-R213

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02654093

Enrollment

Registered

2016-01-13

Start date

2016-01-31

Completion date

2016-03-31

Last updated

2016-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGCholecalciferol

DRUGRaloxifene

DRUGCholecalciferol and Raloxifene co-administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026