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

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Multiple Oral Dose of (Drug); Multiple Oral Dose of (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
Kyun-Seop Bae, M.D., Ph.D., Principal Investigator, Affiliation: Asan Medical Center

Summary

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

Clinical Details

Official 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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Safety (normal results for safety tests)

Eligibility

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Asan Medical Center, Seoul, Korea, Republic of
Additional Information

Clinical Research Center, Asan Medical Center

Starting date: October 2010
Last updated: June 24, 2011

Page last updated: August 23, 2015

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