NCT01406431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 3, 2013

Status Verified

January 1, 2013

Enrollment Period

Same day

First QC Date

July 26, 2011

Last Update Submit

January 1, 2013

Conditions

HyperlipidemiaHypertension

Keywords

pitavastatinLivalo

Outcome Measures

Primary Outcomes (2)

  • Cmax of study drugs after single oral administration

    0-48hrs

  • AUClast of study drugs after single oral administration

    0-48hrs

Secondary Outcomes (1)

  • AUCinf, Tmax and t1/2β of study drugs after single oral administration

    0-48hrs

Study Arms (2)

Pitavastatin + Valsartan

ACTIVE COMPARATOR

Intervention: Drug: Pitavastatin, Valsartan

Drug: Pitavastatin, Valsartan

Livalo fixed combination drug

EXPERIMENTAL

Intervention: Drug: Livalo® fixed combination drug

Drug: Livalo® fixed combination drug

Interventions

Pitavastatin, ValsartanDRUG

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

Also known as: Livalo, Diovan
Pitavastatin + Valsartan
Livalo® fixed combination drugDRUG

Livalo® fixed combination drug(1 tablet)

Also known as: Livalo, Diovan
Livalo fixed combination drug

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Received other investigational drug within 90 days prior to the first dose of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

HyperlipidemiasHypertension

Interventions

pitavastatinValsartan

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Kyun Seop Bae, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2011

First Posted

August 1, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2011

Study Completion

October 1, 2012

Last Updated

January 3, 2013

Record last verified: 2013-01

Locations

KR(1)