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NCT02029625 Clinical Trial

Compare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe

Dyslipidemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02029625
Other study ID # NVP-1205-01
Secondary ID
Status Completed
Phase Phase 1
First received January 5, 2014
Last updated March 24, 2016
Start date February 2014
Est. completion date March 2014

Study information
Verified date March 2016
Source Navipharm Corporation
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.

Description:

rosuvastatin and ezetimibe(anti-dyslipidemia)

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• NVP-1205
rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2
• rosuvastatin and ezetimibe
coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2

Locations
Country Name City State
Korea, Republic of Kyungpook National Hospital Jung-gu Daegu

Sponsors (1)
Lead Sponsor Collaborator
Navipharm Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUClast 0-96hr No
Secondary AUCinf 0-96hr No
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