NCT01232049

Brief Summary

This study is designed to evaluate a pharmacokinetic drug interaction and safety between Pitavastatin and Valsartan in healthy male subjects

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

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

Study Start

First participant enrolled

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Last Updated

June 27, 2011

Status Verified

October 1, 2010

Enrollment Period

5 months

First QC Date

November 1, 2010

Last Update Submit

June 24, 2011

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Safety (normal results for safety tests)

    Adverse events Physical examination, vital signs

    39days

Study Arms (3)

A

EXPERIMENTAL

Pitavastatin 4mg

Drug: Multiple Oral Dose of

B

EXPERIMENTAL

Valsartan 320mg

Drug: Multiple Oral Dose of

C

EXPERIMENTAL

Pitavastatin 4mg + Valsartan 320mg

Drug: Multiple Oral Dose of

Interventions

Multiple Oral Dose ofDRUG

Pitavastatin 4mg

Also known as: Livalo®
AC

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult males aged 20 to 50 years at screening.
  • No significant congenital/chronic disease. No symptoms in physical examination.
  • Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
  • Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

You may not qualify if:

  • History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
  • History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
  • History of known hypersensitivity to drugs including valsartan and pitavastatin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Jung JA, Noh YH, Jin S, Kim MJ, Kim YH, Jung JA, Lim HS, Bae KS. Pharmacokinetic interaction between pitavastatin and valsartan: a randomized, open-labeled crossover study in healthy male Korean volunteers. Clin Ther. 2012 Apr;34(4):958-65. doi: 10.1016/j.clinthera.2012.01.026. Epub 2012 Mar 10.

    PMID: 22410289DERIVED

Related Links

MeSH Terms

Interventions

pitavastatinValsartan

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Kyun-Seop Bae, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2011

Last Updated

June 27, 2011

Record last verified: 2010-10

Locations

KR(1)