NCT01764178

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
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

January 22, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2013

Completed
Last Updated

September 9, 2025

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

January 1, 2013

Last Update Submit

September 2, 2025

Conditions

HyperlipidemiaHypertension

Keywords

PitavastatinValsartan

Outcome Measures

Primary Outcomes (1)

  • Cmax and AUC of study drugs after single oral administration

    0-48hrs

Secondary Outcomes (3)

  • AUCinf of study drugs after single oral administration

    0-48hrs

  • t1/2β of study drugs after single oral administration

    0-48hrs

  • Tmax of study drugs after single oral administration

    0-48hrs

Study Arms (2)

Livalo fixed combination drug

EXPERIMENTAL

Livalo fixed combination drug(Pitavastatin + Valsartan)

Drug: Livalo fixed combination drug

Pitavastatin + Valsartan

ACTIVE COMPARATOR

Pitavastatin, Valsartan

Drug: Pitavastatin, Valsartan

Interventions

Livalo fixed combination drugDRUG

Pitavastatin 4mg / Valsartan 160mg

Livalo fixed combination drug
Pitavastatin, ValsartanDRUG

Pitavastatin 4mg, Valsartan 160mg

Also known as: Livalo, Diovan
Pitavastatin + Valsartan

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, 138-736, 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
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2013

First Posted

January 9, 2013

Study Start

January 22, 2013

Primary Completion

March 15, 2013

Study Completion

December 27, 2013

Last Updated

September 9, 2025

Record last verified: 2017-03

Locations

KR(1)