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Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

Sponsor
JW Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT01764178
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
11.1
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Livalo fixed combination drug
  • Drug: Pitavastatin, Valsartan
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
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
Actual Study Start Date :
Jan 22, 2013
Actual Primary Completion Date :
Mar 15, 2013
Actual Study Completion Date :
Dec 27, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Livalo, Diovan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax and AUC of study drugs after single oral administration [0-48hrs]

    Secondary Outcome Measures

    1. AUCinf of study drugs after single oral administration [0-48hrs]

    2. t1/2β of study drugs after single oral administration [0-48hrs]

    3. Tmax of study drugs after single oral administration [0-48hrs]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of 138-736

    Sponsors and Collaborators

    • JW Pharmaceutical

    Investigators

    • Principal Investigator: Kyun Seop Bae, MD, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JW Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT01764178
    Other Study ID Numbers:
    • JW-PTV-102A
    First Posted:
    Jan 9, 2013
    Last Update Posted:
    Mar 10, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by JW Pharmaceutical
    Pitavastatin
    Valsartan
    Additional relevant MeSH terms:
    Hyperlipidemias
    Valsartan
    Pitavastatin

    Study Results

    No Results Posted as of Mar 10, 2017