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

This study has been completed.
Sponsor:
Collaborator:
JW Pharmaceutical
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01232049
First received: November 1, 2010
Last updated: June 24, 2011
Last verified: October 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 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:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Safety (normal results for safety tests) [ Time Frame: 39days ] [ Designated as safety issue: Yes ]
    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®

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232049

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

Additional Information:
Clinical Research Center, Asan Medical Center  This link exits the ClinicalTrials.gov site

No publications provided by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ChoongWae Parma Corporation, Clinical Research Team
ClinicalTrials.gov Identifier: NCT01232049     History of Changes
Other Study ID Numbers: 2010-0577
Study First Received: November 1, 2010
Last Updated: June 24, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
healthy volunteers

Additional relevant MeSH terms:
Valsartan
Pitavastatin
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
 Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 16, 2013