to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers

NCT ID: NCT02289430

Last Updated: 2016-03-25

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

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-02-28

Brief Summary

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The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.

Detailed Description

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drug interaction : rosuvastatin, ezetimibe

Conditions

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Healthy

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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Crestor+Ezetrol

rosuvastatin+ezetimibe

Group Type EXPERIMENTAL

Crestor+Ezetrol

Intervention Type DRUG

rosuvastatin+ezetimibe

Ezetrol

ezetimibe

Group Type ACTIVE_COMPARATOR

Ezetrol

Intervention Type DRUG

ezetimibe

Crestor

rosuvastatin

Group Type ACTIVE_COMPARATOR

Crestor

Intervention Type DRUG

rosuvastatin

Interventions

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Crestor+Ezetrol

rosuvastatin+ezetimibe

Intervention Type DRUG

Ezetrol

ezetimibe

Intervention Type DRUG

Crestor

rosuvastatin

Intervention Type DRUG

Other Intervention Names

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rosuvatatin+ezetimibe ezetimibe rosuvastatin

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects age between 19 and 45 singed informed consent

Exclusion Criteria

* Hypotension or hypertension has a history of allergy reaction of this drug or other drugs
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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NVP Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shin D Seong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Other Identifiers

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NVP-1205-02

Identifier Type: -

Identifier Source: org_study_id

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