Back to resultsCompare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe (NVP-1205)
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NVP-1205
rosuvastatin and ezetimibe
Sponsored by
About this trial
This is an interventional screening trial for Dyslipidemia
Eligibility Criteria
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
Sites / Locations
- Kyungpook National Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NVP-1205
rosuvastatin and ezetimibe
Arm Description
administration of NVP-1205(rosuvastatin+ezetimibe)
coadministration of rosuvastatin and ezetimibe
Outcomes
Primary Outcome Measures
AUClast
Secondary Outcome Measures
AUCinf
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02029625
Brief Title
Compare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe
Acronym
NVP-1205
Official Title
A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NVP Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.
Detailed Description
rosuvastatin and ezetimibe(anti-dyslipidemia)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NVP-1205
Arm Type
Experimental
Arm Description
administration of NVP-1205(rosuvastatin+ezetimibe)
Arm Title
rosuvastatin and ezetimibe
Arm Type
Active Comparator
Arm Description
coadministration of rosuvastatin and ezetimibe
Intervention Type
Drug
Intervention Name(s)
NVP-1205
Other Intervention Name(s)
NVP-1205(rosuvastatin+ezetimibe)
Intervention Description
rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2
Intervention Type
Drug
Intervention Name(s)
rosuvastatin and ezetimibe
Other Intervention Name(s)
Crestor and Ezetrol
Intervention Description
coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2
Primary Outcome Measure Information:
Title
AUClast
Time Frame
0-96hr
Secondary Outcome Measure Information:
Title
AUCinf
Time Frame
0-96hr
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon Yo Ran, M.D., Ph,D.
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National Hospital
City
Jung-gu
State/Province
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Compare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe
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