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

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multiple Oral Dose of

Drug

Pitavastatin 4mg

Other names: Livalo®

Primary outcomes

Safety (normal results for safety tests)

Time frame: 39days

Adverse events Physical examination, vital signs

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

JW Pharmaceutical

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
First posted: Nov 2, 2010
Registry last updated: Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed