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Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764178
First Posted: January 9, 2013
Last Update Posted: March 10, 2017
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: Livalo fixed combination drug Drug: Pitavastatin, Valsartan Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare Pharmacokinetics Between Pitavastatn and Valsartan Co-administration and Livalo Complex Product in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

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

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

Enrollment: 52
Actual Study Start Date: January 22, 2013
Study Completion Date: December 27, 2013
Primary Completion Date: March 15, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Livalo fixed combination drug
Livalo fixed combination drug(Pitavastatin + Valsartan)
Drug: Livalo fixed combination drug
Pitavastatin 4mg / Valsartan 160mg
Active Comparator: Pitavastatin + Valsartan
Pitavastatin, Valsartan
Drug: Pitavastatin, Valsartan
Pitavastatin 4mg, Valsartan 160mg
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): NCT01764178


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Principal Investigator: Kyun Seop Bae, MD Asan Medical Center
  More Information

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01764178     History of Changes
Other Study ID Numbers: JW-PTV-102A
First Submitted: January 1, 2013
First Posted: January 9, 2013
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by JW Pharmaceutical:
Pitavastatin
Valsartan

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