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A Study to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone

NCT ID: NCT02730689

Last Updated: 2016-04-06

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this study is to compare the pharmacokinetics of DP-R207 (Rosuvastatin 10mg and Ezetimibe 10mg fixed dose combinations) in comparison to each component administered alone in health male volunteers.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A group

DP-R207 \>\> rosuvastatin+ezetimibe

Group Type EXPERIMENTAL

DP-R207

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Ezetimibe

Intervention Type DRUG

B group

rosuvastatin+ezetimibe \>\> DP-R207

Group Type ACTIVE_COMPARATOR

DP-R207

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Ezetimibe

Intervention Type DRUG

Interventions

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DP-R207

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Ezetimibe

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects age between 19 and 55 signed informed consent

Exclusion Criteria

* subjects have an allergy reaction of this drug
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 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-CTR207-I-03

Identifier Type: -

Identifier Source: org_study_id

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