Compare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe

NCT ID: NCT02029625

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

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-03-31

Brief Summary

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The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.

Detailed Description

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rosuvastatin and ezetimibe(anti-dyslipidemia)

Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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NVP-1205

administration of NVP-1205(rosuvastatin+ezetimibe)

Group Type EXPERIMENTAL

NVP-1205

Intervention Type DRUG

rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2

rosuvastatin and ezetimibe

coadministration of rosuvastatin and ezetimibe

Group Type ACTIVE_COMPARATOR

rosuvastatin and ezetimibe

Intervention Type DRUG

coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2

Interventions

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NVP-1205

rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2

Intervention Type DRUG

rosuvastatin and ezetimibe

coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2

Intervention Type DRUG

Other Intervention Names

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NVP-1205(rosuvastatin+ezetimibe) Crestor and Ezetrol

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* subjects have a history of allergy reaction of this drug or other drugs
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 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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Yoon Yo Ran, M.D., Ph,D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook National Hospital

Jung-gu, Daegu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NVP-1205-01

Identifier Type: -

Identifier Source: org_study_id

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