Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01406431
First received: July 26, 2011
Last updated: January 1, 2013
Last verified: January 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • AUClast of study drugs after single oral administration [ Time Frame: 0-48hrs ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01406431     History of Changes
Other Study ID Numbers: JW-PTV-102
Study First Received: July 26, 2011
Last Updated: January 1, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by JW Pharmaceutical:
pitavastatin
Livalo

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
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 July 22, 2014