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Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

This study is not yet open for participant recruitment.
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
History of Changes
  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:

U.S. FDA Resources

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
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:
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 May 22, 2013