Back to resultsPharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects
Primary Purpose
Hyperlipidemia, Hypertension
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Livalo fixed combination drug
Pitavastatin, Valsartan
Sponsored by
About this trial
This is an interventional other trial for Hyperlipidemia focused on measuring Pitavastatin, Valsartan
Eligibility 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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Livalo fixed combination drug
Pitavastatin + Valsartan
Arm Description
Livalo fixed combination drug(Pitavastatin + Valsartan)
Pitavastatin, Valsartan
Outcomes
Primary Outcome Measures
Cmax and AUC of study drugs after single oral administration
Secondary Outcome Measures
AUCinf of study drugs after single oral administration
t1/2β of study drugs after single oral administration
Tmax of study drugs after single oral administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01764178
Brief Title
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 22, 2013 (Actual)
Primary Completion Date
March 15, 2013 (Actual)
Study Completion Date
December 27, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Hypertension
Keywords
Pitavastatin, Valsartan
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Livalo fixed combination drug
Arm Type
Experimental
Arm Description
Livalo fixed combination drug(Pitavastatin + Valsartan)
Arm Title
Pitavastatin + Valsartan
Arm Type
Active Comparator
Arm Description
Pitavastatin, Valsartan
Intervention Type
Drug
Intervention Name(s)
Livalo fixed combination drug
Intervention Description
Pitavastatin 4mg / Valsartan 160mg
Intervention Type
Drug
Intervention Name(s)
Pitavastatin, Valsartan
Other Intervention Name(s)
Livalo, Diovan
Intervention Description
Pitavastatin 4mg, Valsartan 160mg
Primary Outcome Measure Information:
Title
Cmax and AUC of study drugs after single oral administration
Time Frame
0-48hrs
Secondary Outcome Measure Information:
Title
AUCinf of study drugs after single oral administration
Time Frame
0-48hrs
Title
t1/2β of study drugs after single oral administration
Time Frame
0-48hrs
Title
Tmax of study drugs after single oral administration
Time Frame
0-48hrs
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyun Seop Bae, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects
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