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Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01406431
First Posted: August 1, 2011
Last Update Posted: January 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JW Pharmaceutical
July 26, 2011
August 1, 2011
January 3, 2013
August 2011
August 2011   (Final data collection date for primary outcome measure)
  • Cmax of study drugs after single oral administration [ Time Frame: 0-48hrs ]
  • AUClast of study drugs after single oral administration [ Time Frame: 0-48hrs ]
Cmax and AUClast of study drugs after single oral administration [ Time Frame: 0-48hrs ]
Complete list of historical versions of study NCT01406431 on ClinicalTrials.gov Archive Site
AUCinf, Tmax and t1/2β of study drugs after single oral administration [ Time Frame: 0-48hrs ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects
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
The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
  • Hyperlipidemia
  • Hypertension
  • Drug: Pitavastatin, Valsartan
    Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)
    Other Name: Livalo, Diovan
  • Drug: Livalo® fixed combination drug
    Livalo® fixed combination drug(1 tablet)
    Other Name: Livalo, Diovan
  • Active Comparator: Pitavastatin + Valsartan
    Intervention: Drug: Pitavastatin, Valsartan
    Intervention: Drug: Pitavastatin, Valsartan
  • Experimental: Livalo fixed combination drug
    Intervention: Drug: Livalo® fixed combination drug
    Intervention: Drug: Livalo® fixed combination drug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
October 2012
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01406431
JW-PTV-102
No
Not Provided
Not Provided
JW Pharmaceutical
JW Pharmaceutical
Not Provided
Principal Investigator: Kyun Seop Bae, MD Asan Medical Center
JW Pharmaceutical
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP