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to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers (NVP-1205)

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ClinicalTrials.gov Identifier: NCT02289430
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
Navipharm Corporation

Brief Summary:
The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.

Condition or disease Intervention/treatment Phase
Healthy Drug: Crestor+Ezetrol Drug: Ezetrol Drug: Crestor Phase 1

Detailed Description:
drug interaction : rosuvastatin, ezetimibe

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers
Study Start Date : December 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Crestor+Ezetrol
rosuvastatin+ezetimibe
Drug: Crestor+Ezetrol
rosuvastatin+ezetimibe
Other Name: rosuvatatin+ezetimibe

Active Comparator: Ezetrol
ezetimibe
Drug: Ezetrol
ezetimibe
Other Name: ezetimibe

Active Comparator: Crestor
rosuvastatin
Drug: Crestor
rosuvastatin
Other Name: rosuvastatin




Primary Outcome Measures :
  1. Area Under Curve [ Time Frame: 0-24h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects age between 19 and 45 singed informed consent

Exclusion Criteria:

  • Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

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): NCT02289430


Sponsors and Collaborators
Navipharm Corporation
Investigators
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Principal Investigator: Shin D Seong, M.D. Gachon University Gil Medical Center

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Responsible Party: Navipharm Corporation
ClinicalTrials.gov Identifier: NCT02289430     History of Changes
Other Study ID Numbers: NVP-1205-02
First Posted: November 13, 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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Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors