A Drug-drug Interaction Study of DP-R213

March 10, 2016 updated by: Alvogen Korea

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Daegu
      • Jung-gu, Daegu, Korea, Republic of, 41940
        • Kyungbook National university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
-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
-20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvogen Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP-CTR213-I-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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