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

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ClinicalTrials.gov Identifier: NCT02029625
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
NVP Healthcare

Study Description
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Brief Summary:
The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: NVP-1205 Drug: rosuvastatin and ezetimibe Phase 1

Detailed Description:
rosuvastatin and ezetimibe(anti-dyslipidemia)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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 Start Date : February 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: NVP-1205
administration of NVP-1205(rosuvastatin+ezetimibe)
 Drug: NVP-1205
rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2
Other Name: NVP-1205(rosuvastatin+ezetimibe)
Active Comparator: rosuvastatin and ezetimibe
coadministration of rosuvastatin and ezetimibe
 Drug: rosuvastatin and ezetimibe
coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2
Other Name: Crestor and Ezetrol


Outcome Measures
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Primary Outcome Measures :
  1. AUClast [ Time Frame: 0-96hr ]

Secondary Outcome Measures :
  1. AUCinf [ Time Frame: 0-96hr ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029625


Locations
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Korea, Republic of
Kyungpook National Hospital
Jung-gu, Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
NVP Healthcare
Investigators
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Principal Investigator: Yoon Yo Ran, M.D., Ph,D. Kyungpook National University Hospital
More Information
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Responsible Party: NVP Healthcare
ClinicalTrials.gov Identifier: NCT02029625    
Other Study ID Numbers: NVP-1205-01
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors