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Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01406431
First Posted: August 1, 2011
Last Update Posted: January 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JW Pharmaceutical
  Purpose
The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.

Condition Intervention Phase
Hyperlipidemia Hypertension Drug: Pitavastatin, Valsartan Drug: Livalo® fixed combination drug Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare Pharmacokinetics Between Pitavastatin and Valsartan Co-administration and Livalo® Fixed Combination Drug in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Cmax of study drugs after single oral administration [ Time Frame: 0-48hrs ]
  • AUClast of study drugs after single oral administration [ Time Frame: 0-48hrs ]

Secondary Outcome Measures:
  • AUCinf, Tmax and t1/2β of study drugs after single oral administration [ Time Frame: 0-48hrs ]

Enrollment: 48
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pitavastatin + Valsartan
Intervention: Drug: Pitavastatin, Valsartan
Drug: Pitavastatin, Valsartan
Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)
Other Name: Livalo, Diovan
Experimental: Livalo fixed combination drug
Intervention: Drug: Livalo® fixed combination drug
Drug: Livalo® fixed combination drug
Livalo® fixed combination drug(1 tablet)
Other Name: Livalo, Diovan

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers
  • Age 20-55 years at the time of Screening
  • BMI 19-26 kg/m2 at the time of Screening

Exclusion Criteria:

  • Received other investigational drug within 90 days prior to the first dose of study drug
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406431


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Principal Investigator: Kyun Seop Bae, MD Asan Medical Center
  More Information

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01406431     History of Changes
Other Study ID Numbers: JW-PTV-102
First Submitted: July 26, 2011
First Posted: August 1, 2011
Last Update Posted: January 3, 2013
Last Verified: January 2013

Keywords provided by JW Pharmaceutical:
pitavastatin
Livalo

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Valsartan
Pitavastatin
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents