Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

JW Pharmaceutical

ClinicalTrials.gov Identifier:

NCT01406431

First received: July 26, 2011

Last updated: January 1, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 26, 2011

Last Updated Date

January 1, 2013

Start Date ^ICMJE

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cmax of study drugs after single oral administration [ Time Frame: 0-48hrs ] [ Designated as safety issue: Yes ]
AUClast of study drugs after single oral administration [ Time Frame: 0-48hrs ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Cmax and AUClast of study drugs after single oral administration [ Time Frame: 0-48hrs ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01406431 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AUCinf, Tmax and t1/2β of study drugs after single oral administration [ Time Frame: 0-48hrs ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

Official Title ^ICMJE

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

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Hyperlipidemia
Hypertension

Intervention ^ICMJE

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

Other Name: Livalo, Diovan
Drug: Livalo® fixed combination drug
Livalo® fixed combination drug(1 tablet)

Other Name: Livalo, Diovan

Study Arm (s)

Active Comparator: Pitavastatin + Valsartan
Intervention: Drug: Pitavastatin, Valsartan

Intervention: Drug: Pitavastatin, Valsartan
Experimental: Livalo fixed combination drug
Intervention: Drug: Livalo® fixed combination drug

Intervention: Drug: Livalo® fixed combination drug

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01406431

Other Study ID Numbers ^ICMJE

JW-PTV-102

Has Data Monitoring Committee

Responsible Party

JW Pharmaceutical

Study Sponsor ^ICMJE

JW Pharmaceutical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kyun Seop Bae, MD

Asan Medical Center

Information Provided By

JW Pharmaceutical

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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