DP-R213 Pharmacokinetics Study

NCT ID: NCT02762643

Last Updated: 2016-11-01

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

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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DP-R213

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RT group

combination dose of Raloxifene and Cholecaliferol and DP-R213 in order

Group Type EXPERIMENTAL

DP-R213

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Raloxifene

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Cholecaliferol

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

TR group

combination dose of Raloxifene and Cholecaliferol and DP-R213 in order

Group Type EXPERIMENTAL

DP-R213

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Raloxifene

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Cholecaliferol

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Interventions

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DP-R213

Investigational product is prescribed to all of randomized subjects

Intervention Type DRUG

Raloxifene

Investigational product is prescribed to all of randomized subjects

Intervention Type DRUG

Cholecaliferol

Investigational product is prescribed to all of randomized subjects

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DP-CTR213-I-01

Identifier Type: -

Identifier Source: org_study_id