CKD-337 Drug Interaction Study

August 7, 2017 updated by: Chong Kun Dang Pharmaceutical

Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Fenofibrate and Atorvastatin in Healthy Male Volunteers

The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy 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

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • A healthy male volunteer between 19 and 55 years old.
  • BMI between 18.5 and 27.
  • Able to participate in the entire trial
  • Signed the informed consent form prior to study participation.

Exclusion Criteria:

  • Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system
  • sit SBP < 100mmHg or sit SBP ≥ 150mmHg or sit DBP < 70mmHg or sit DBP ≥ 100mmHg
  • Have acute infection history within 14 days
  • Have a allergic disease of need to treat
  • Have hypersensitivity reactions history for IP or any specific drugs.
  • AST, ALT or Total bilirubin > UNL * 1.5
  • Estimated GFR < 60 ml/min
  • Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • A heavy smoker (cigarette > 10 cigarettes per day)
  • A heavy alcohol consumer (alcohol > 140g/week)
  • A heavy grapefruit consumer (more than 1cup per a day)
  • Have a history of drug abuse or showed a positive for urine drug test.
  • Administrated IP within 60 days prior to screening
  • Rhabdomyolysis include of having a history or family history of genetic muscle diseases
  • Positive for HIV antibody, HBsAg, HCV antibody test
  • Previously donate whole blood within 60 days or component blood within 30 days
  • Subject takes ethical drug or herbal medicine within 30 days
  • Clinically significant laboratory test result
  • An impossible one who participates in clinical trial by investigator's decision including other reason

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: Fenofibrate
Subjects received Fenofibrate
Drug: Fenofibrate
Experimental: Atorvastatin
Subjects received Atorvastatin
Drug: Atorvastatin
Experimental: Fenofibrate and Atorvastatin
Subjects received Fenofibrate and Atorvastatin
Drug: Atorvastatin
Drug: Fenofibrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCt, Cmax,ss of fenofibric acid and atorvastatin
Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h

Secondary Outcome Measures

Outcome Measure
Time Frame
Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation
Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h

Collaborators and Investigators

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

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Wooseong Huh, M.D., Ph.D., Samsung 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 (Actual)

March 18, 2014

Primary Completion (Actual)

April 7, 2014

Study Completion (Actual)

May 29, 2014

Study Registration Dates

First Submitted

February 16, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 146DDI13024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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