DP-R213 Pharmacokinetics Study

October 31, 2016 updated by: Alvogen Korea

An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects

A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 1

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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • IBW ±20%
  • signed the informed consent form prior to the study participation

Exclusion Criteria:

  • Clinically significant disease
  • Previously donate whole blood within 2 months or component blood within 1 month
  • Clinically significant allergic disease
  • Taken IP in other trial within 3 months
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RT group
combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
Drug: DP-R213
Investigational product is prescribed to all of randomized subjects
Drug: Raloxifene
Investigational product is prescribed to all of randomized subjects
Drug: Cholecaliferol
Investigational product is prescribed to all of randomized subjects
Experimental: TR group
combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
Drug: DP-R213
Investigational product is prescribed to all of randomized subjects
Drug: Raloxifene
Investigational product is prescribed to all of randomized subjects
Drug: Cholecaliferol
Investigational product is prescribed to all of randomized subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC)
Time Frame: up to 96 hours post dose
up to 96 hours post dose
Peak Plasma Concentration (Cmax)
Time Frame: up to 96 hours post dose
up to 96 hours post dose

Collaborators and Investigators

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

Sponsor

Alvogen Korea

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

May 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 29, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP-CTR213-I-01

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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