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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:
NCT01764178
First received: January 1, 2013
Last updated: March 8, 2017
Last verified: March 2017
  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: No masking
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

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
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
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
Study First Received: January 1, 2013
Last Updated: March 8, 2017

Keywords provided by JW Pharmaceutical:
Pitavastatin
Valsartan

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

ClinicalTrials.gov processed this record on April 28, 2017