CKD-337(2) Drug-drug Interaction Study

August 7, 2017 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Open-label, Multiple Dosing, 3-way Crossover Study to Evaluate the Drug-drug Interaction Between Atorvastatin and Fenofibric Acid in Healthy Male Volunteers

The purpose of this study is to evaluate the pharmacokinetic interaction between Atorvastatin and Fenofibric acid.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a randomized, open-label, multiple dosing, 3-way crossover design to evaluate the drug-drug interaction between Atorvastatin (Lipitor) and Fenofibric (Trilipix) acid in healthy male subjects. Subjects will receive repeated dose of Atorvastatin (40mg*1Tab/day) or Fenofibric acid (135mg*1Cap/day) or Atorvastatin (40mg*1Tab/day)/Fenofibric acid (135mg*1Cap/day). Each treatment period was separated by a washout period of at least 8 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Jeonju-si, Jeollabuk-do
      • Deokjin-gu, Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
        • Chonbuk National University 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy man older than 19 years at the time of screening.
  • BMI more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 55kg
  • Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
  • Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
  • Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
  • Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.

Exclusion Criteria:

  1. Subject who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
  2. Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
  3. Showing the value that corresponds to following laboratory parameters: AST or AST or CK > 2* upper limit of normal range.
  4. Alcohol > 210g/week, within 6 months prior to the screening.
  5. Taking the medication involved in other clinical trials within two months before the first dose medication characters.
  6. Sitting Systolic Blood Pressure ≥ 140 mmHg, Diastolic Blood Pressure ≥ 90 mmHg at the time of screening.
  7. History of alcohol or drug abuse, within 1 year
  8. Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
  9. Smoker (> 20cigarettes/day)
  10. Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
  11. Subject who done the whole blood donation within two months or component blood donation within 1 month within 1 month prior to the first dosing.
  12. Subject who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
  13. Subject with serious history of hypersensitivity or allergy to investigational product.
  14. Active liver disease.
  15. Muscle disease.
  16. Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
  17. Patients with severe hepatic impairment or Gallbladder Disease.
  18. Patients with moderate to severe renal impairment.
  19. Patients experienced allergy or phototoxicity during treatment with fibrate or ketoprofen.
  20. Subjects who is not able to comply with guidelines described in the protocol.
  21. Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group1: TreatmentA+TreatmentB+TreatmentC
TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Drug: Lipitor Tab. 40mg
Other Names:
  • Atorvastatin 40mg
Drug: Trilipix 135mg
Other Names:
  • Fenofibric acid 135mg
Experimental: Group2: TreatmentC+TreatmentA+TreatmentB
TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Drug: Lipitor Tab. 40mg
Other Names:
  • Atorvastatin 40mg
Drug: Trilipix 135mg
Other Names:
  • Fenofibric acid 135mg
Experimental: Group3: TreatmentB+TreatmentC+TreatmentA
TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Drug: Lipitor Tab. 40mg
Other Names:
  • Atorvastatin 40mg
Drug: Trilipix 135mg
Other Names:
  • Fenofibric acid 135mg
Experimental: Group4: TreatmentC+TreatmentB+TreatmentA
TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Drug: Lipitor Tab. 40mg
Other Names:
  • Atorvastatin 40mg
Drug: Trilipix 135mg
Other Names:
  • Fenofibric acid 135mg
Experimental: Group5: TreatmentB+TreatmentA+TreatmentC
TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Drug: Lipitor Tab. 40mg
Other Names:
  • Atorvastatin 40mg
Drug: Trilipix 135mg
Other Names:
  • Fenofibric acid 135mg
Experimental: Group6: TreatmentA+TreatmentC+TreatmentB
TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Drug: Lipitor Tab. 40mg
Other Names:
  • Atorvastatin 40mg
Drug: Trilipix 135mg
Other Names:
  • Fenofibric acid 135mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Atorvastatin and Fenofibric acid AUCτ
Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks
Atorvastatin and Fenofibric acid Css,max
Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Atorvastatin and Fenofibric acid Css,min
Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks
Atorvastatin and Fenofibric acid Css,av
Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks
2-hydroxyatorvastatin AUCτ
Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks
2-hydroxyatorvastatin Css,max
Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Min Gul Kim, Chonbuk National University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 146DDI14030

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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