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To Evaluate the Safety and PK Characteristics in Healthy Volunteers-Livalozet

NCT ID: NCT01764178

Last Updated: 2025-09-09

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-22

Study Completion Date

2013-12-27

Brief Summary

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The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.

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Detailed Description

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Conditions

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Hyperlipidemia Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Livalo fixed combination drug

Livalo fixed combination drug(Pitavastatin + Valsartan)

Group Type EXPERIMENTAL

Livalo fixed combination drug

Intervention Type DRUG

Pitavastatin 4mg / Valsartan 160mg

Pitavastatin + Valsartan

Pitavastatin, Valsartan

Group Type ACTIVE_COMPARATOR

Pitavastatin, Valsartan

Intervention Type DRUG

Pitavastatin 4mg, Valsartan 160mg

Interventions

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Livalo fixed combination drug

Pitavastatin 4mg / Valsartan 160mg

Intervention Type DRUG

Pitavastatin, Valsartan

Pitavastatin 4mg, Valsartan 160mg

Intervention Type DRUG

Other Intervention Names

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Livalo, Diovan

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers
* Age 20-55 years at the time of Screening
* BMI 19-26 kg/m2 at the time of Screening

Exclusion Criteria

* Received other investigational drug within 90 days prior to the first dose of study drug
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyun Seop Bae, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JW-PTV-102A

Identifier Type: -

Identifier Source: org_study_id

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