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

March 24, 2016 updated by: NVP Healthcare

A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

drug interaction : rosuvastatin, ezetimibe

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crestor+Ezetrol
rosuvastatin+ezetimibe
Drug: Crestor+Ezetrol
rosuvastatin+ezetimibe
Other Names:
  • rosuvatatin+ezetimibe
Active Comparator: Ezetrol
ezetimibe
Drug: Ezetrol
ezetimibe
Other Names:
  • ezetimibe
Active Comparator: Crestor
rosuvastatin
Drug: Crestor
rosuvastatin
Other Names:
  • rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under Curve
Time Frame: 0-24h
0-24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NVP Healthcare

Investigators

  • Principal Investigator: Shin D Seong, M.D., Gachon University Gil Medical Center

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

December 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 9, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 13, 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-1205-02

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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