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

This study has been completed.
JW Pharmaceutical
Information provided by:
Asan Medical Center Identifier:
First received: November 1, 2010
Last updated: June 24, 2011
Last verified: October 2010
This study is designed to evaluate a pharmacokinetic drug interaction and safety between Pitavastatin and Valsartan in healthy male subjects

Condition Intervention Phase
Drug: Multiple Oral Dose of
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Safety (normal results for safety tests) [ Time Frame: 39days ]
    Adverse events Physical examination, vital signs

Estimated Enrollment: 24
Study Start Date: October 2010
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Pitavastatin 4mg
Drug: Multiple Oral Dose of
Pitavastatin 4mg
Other Name: Livalo®
Experimental: B
Valsartan 320mg
Drug: Multiple Oral Dose of
Valsartan 320mg
Other Name: Diovan®
Experimental: C
Pitavastatin 4mg + Valsartan 320mg
Drug: Multiple Oral Dose of
Pitavastatin 4mg
Other Name: Livalo®
Drug: Multiple Oral Dose of
Valsartan 320mg
Other Name: Diovan®


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01232049

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
JW Pharmaceutical
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ChoongWae Parma Corporation, Clinical Research Team Identifier: NCT01232049     History of Changes
Other Study ID Numbers: 2010-0577
Study First Received: November 1, 2010
Last Updated: June 24, 2011

Keywords provided by Asan Medical Center:
healthy volunteers

Additional relevant MeSH terms:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on April 28, 2017