Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and Fenofibric Acid in Healthy Male Volunteers

February 12, 2014 updated by: Daewoong Pharmaceutical Co. LTD.

An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Rosuvastatin and Fenofibric Acid in Healthy Adult Subjects

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Inje University College of Medicine Busan Paik Hospital

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:

  1. Healthy adult male volunteers aged 19 to 45 years
  2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
  3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion Criteria:

  1. A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.

  2. A subject who shows the following result in clinical laboratory test

    • AST, ALT > 1.25 times of the upper limit of normal range
    • PR ≥ 210 msec
    • QRS ≥ 120 msec
    • QT ≥ 500 msec
    • QTcF ≥ 500 msec
  3. Subject who has taken other clinical medication from another clinical trial within 60-day period prior to the first administration of the study medication

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosuvastatin
multiple dose of Rosuvastatin 20mg
Drug: Cresto 20mg
tablet, rosuvastatin 20mg
Experimental: Fenofibric acid
multiple dose of Fenofibric acid 135mg
Drug: Fenofibric acid 135mg
capsule, fenofibric acid 135mg
Experimental: Rosuvastatin + Fenofibric acid
multiple dose of the combination of Rosuvastatin 20mg and Fenofibric acid 135mg
Drug: Cresto 20mg, Fenofibric acid 135mg
rosuvastatin 20mg, Fenofibric acid 135mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax
Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
AUCtau
Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmin
Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Tmax
Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
CL/F
Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
T1/2
Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Metabolic Ratio
Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

Collaborators and Investigators

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

Sponsor

Daewoong Pharmaceutical Co. LTD.

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

September 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 15, 2013

First Posted (Estimate)

October 17, 2013

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWJ1330001

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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