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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:
NCT01406431
First received: July 26, 2011
Last updated: January 1, 2013
Last verified: January 2013

July 26, 2011
January 1, 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 ] [ Designated as safety issue: Yes ]
  • AUClast of study drugs after single oral administration [ Time Frame: 0-48hrs ] [ Designated as safety issue: Yes ]
Cmax and AUClast of study drugs after single oral administration [ Time Frame: 0-48hrs ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01406431
JW-PTV-102
No
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