Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

January 1, 2013 updated by: JW Pharmaceutical

A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare Pharmacokinetics Between Pitavastatin and Valsartan Co-administration and Livalo® Fixed Combination Drug in Healthy Male Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pitavastatin + Valsartan
Intervention: Drug: Pitavastatin, Valsartan
Drug: Pitavastatin, Valsartan
Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)
Other Names:
  • Livalo, Diovan
Experimental: Livalo fixed combination drug
Intervention: Drug: Livalo® fixed combination drug
Drug: Livalo® fixed combination drug
Livalo® fixed combination drug(1 tablet)
Other Names:
  • Livalo, Diovan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of study drugs after single oral administration
Time Frame: 0-48hrs
0-48hrs
AUClast of study drugs after single oral administration
Time Frame: 0-48hrs
0-48hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
AUCinf, Tmax and t1/2β of study drugs after single oral administration
Time Frame: 0-48hrs
0-48hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Kyun Seop Bae, MD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

August 1, 2011

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 1, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JW-PTV-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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