- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01764178
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects
March 8, 2017 updated by: JW Pharmaceutical
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
The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 138-736
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Livalo fixed combination drug
Livalo fixed combination drug(Pitavastatin + Valsartan)
|
Pitavastatin 4mg / Valsartan 160mg
|
Active Comparator: Pitavastatin + Valsartan
Pitavastatin, Valsartan
|
Pitavastatin 4mg, Valsartan 160mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax and AUC of study drugs after single oral administration
Time Frame: 0-48hrs
|
0-48hrs
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCinf of study drugs after single oral administration
Time Frame: 0-48hrs
|
0-48hrs
|
t1/2β of study drugs after single oral administration
Time Frame: 0-48hrs
|
0-48hrs
|
Tmax of study drugs after single oral administration
Time Frame: 0-48hrs
|
0-48hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kyun Seop Bae, MD, Asan Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 22, 2013
Primary Completion (Actual)
March 15, 2013
Study Completion (Actual)
December 27, 2013
Study Registration Dates
First Submitted
January 1, 2013
First Submitted That Met QC Criteria
January 7, 2013
First Posted (Estimate)
January 9, 2013
Study Record Updates
Last Update Posted (Actual)
March 10, 2017
Last Update Submitted That Met QC Criteria
March 8, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hyperlipidemias
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Valsartan
- Pitavastatin
Other Study ID Numbers
- JW-PTV-102A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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