Drug Interaction and Safety Between Pitavastatin and Valsartan (CWP-PTV-101)

A Randomized, Open-label, Multiple Dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety Between Pitavastatin and Valsartan in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01232049

Enrollment

Registered

2010-11-02

Start date

2010-10-31

Completion date

Unknown

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy volunteers

Brief summary

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

Interventions

DRUGMultiple Oral Dose of

Pitavastatin 4mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Safety (normal results for safety tests)	39days	Adverse events Physical examination, vital signs

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026