Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by JW Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01764178
First received: January 1, 2013
Last updated: January 7, 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: Livalo fixed combination drug
Drug: Pitavastatin, Valsartan
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 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 52
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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

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: NCT01764178

Locations
Korea, Republic of
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 138-736
Contact: Shihyang Lee    +82-2-3010-6052    phase1@amc.seoul.kr   
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: NCT01764178     History of Changes
Other Study ID Numbers: JW-PTV-102A
Study First Received: January 1, 2013
Last Updated: January 7, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by JW Pharmaceutical:
Pitavastatin
Valsartan

Additional relevant MeSH terms:
Hypertension
Hyperlipidemias
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Valsartan
Pitavastatin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on October 01, 2014