Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

NCT ID: NCT01406431

Last Updated: 2013-01-03

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-10-31

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.

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

Blinding Strategy

NONE

Study Groups

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Pitavastatin + Valsartan

Intervention: Drug: Pitavastatin, Valsartan

Group Type ACTIVE_COMPARATOR

Pitavastatin, Valsartan

Intervention Type DRUG

Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)

Livalo fixed combination drug

Intervention: Drug: Livalo® fixed combination drug

Group Type EXPERIMENTAL

Livalo® fixed combination drug

Intervention Type DRUG

Livalo® fixed combination drug(1 tablet)

Interventions

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Pitavastatin, Valsartan

Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)

Intervention Type DRUG

Livalo® fixed combination drug

Livalo® fixed combination drug(1 tablet)

Intervention Type DRUG

Other Intervention Names

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Livalo, Diovan 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-102

Identifier Type: -

Identifier Source: org_study_id

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