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Completed

NCT Number: NCT01406431

Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.

Completed

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Key information

Conditions

Hyperlipidemia Cardiovascular Diseases Dyslipidemias Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pitavastatin, Valsartan

Drug

Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)

Other names: Livalo, Diovan

Livalo® fixed combination drug

Drug

Livalo® fixed combination drug(1 tablet)

Other names: Livalo, Diovan

Primary outcomes

  1. Cmax of study drugs after single oral administration

    Time frame: 0-48hrs

  2. AUClast of study drugs after single oral administration

    Time frame: 0-48hrs

Secondary outcomes

  1. AUCinf, Tmax and t1/2β of study drugs after single oral administration

    Time frame: 0-48hrs

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 1, 2011
Registry last updated
Jan 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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