- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02029625
Compare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe (NVP-1205)
March 24, 2016 updated by: NVP Healthcare
A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe in Healthy Male Volunteers
The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
rosuvastatin and ezetimibe(anti-dyslipidemia)
Study Type
Interventional
Enrollment (Actual)
41
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
-
-
Daegu
-
Jung-gu, Daegu, Korea, Republic of, 700-721
- Kyungpook National Hospital
-
-
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
19 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects age between 19 and 55 signed informed consent
Exclusion Criteria:
- subjects have a history of allergy reaction of this drug or other drugs
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: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NVP-1205
administration of NVP-1205(rosuvastatin+ezetimibe)
|
rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2
Other Names:
|
Active Comparator: rosuvastatin and ezetimibe
coadministration of rosuvastatin and ezetimibe
|
coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUClast
Time Frame: 0-96hr
|
0-96hr
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCinf
Time Frame: 0-96hr
|
0-96hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yoon Yo Ran, M.D., Ph,D., Kyungpook National University Hospital
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
February 1, 2014
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
January 5, 2014
First Submitted That Met QC Criteria
January 6, 2014
First Posted (Estimate)
January 8, 2014
Study Record Updates
Last Update Posted (Estimate)
March 25, 2016
Last Update Submitted That Met QC Criteria
March 24, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NVP-1205-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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