HealthyPhase 1NCT02422030

CKD-337(2) Drug-drug Interaction Study

A Phase 1 study testing Lipitor Tab. 40mg and Trilipix 135mg in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 19 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lipitor Tab. 40mg and Trilipix 135mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSouth Korea
Study dates: 17 Mar 2015to 30 Apr 2015
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)
Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
Showing the value that corresponds to following laboratory parameters: AST or AST or CK > 2* upper limit of normal range.
Alcohol > 210g/week, within 6 months prior to the screening.
Taking the medication involved in other clinical trials within two months before the first dose medication characters.
Sitting Systolic Blood Pressure ≥ 140 mmHg, Diastolic Blood Pressure ≥ 90 mmHg at the time of screening.

Show all 21Show fewer

History of alcohol or drug abuse, within 1 year
Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
Smoker (> 20cigarettes/day)
Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
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.
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.
Subject with serious history of hypersensitivity or allergy to investigational product.
Active liver disease.
Muscle disease.
Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
Patients with severe hepatic impairment or Gallbladder Disease.
Patients with moderate to severe renal impairment.
Patients experienced allergy or phototoxicity during treatment with fibrate or ketoprofen.
Subjects who is not able to comply with guidelines described in the protocol.
Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chonbuk National University Hospital
Deokjin-gu, Jeonju-si, Jeollabuk-do, 561-712

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions: Healthy
Being tested: Lipitor Tab. 40mg, Trilipix 135mg
Keywords: Male Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lipitor Tab. 40mgDrug
Also called Atorvastatin 40mg
Trilipix 135mgDrug
Also called Fenofibric acid 135mg

Study groups in NCT02422030
Study group	Role	What they receive
Group1: TreatmentA+TreatmentB+TreatmentC	Experimental	TreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days. Receives: Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg
Group2: TreatmentC+TreatmentA+TreatmentB	Experimental	TreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days. Receives: Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg
Group3: TreatmentB+TreatmentC+TreatmentA	Experimental	TreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days. Receives: Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg
Group4: TreatmentC+TreatmentB+TreatmentA	Experimental	TreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days. Receives: Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg
Group5: TreatmentB+TreatmentA+TreatmentC	Experimental	TreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days. Receives: Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg
Group6: TreatmentA+TreatmentC+TreatmentB	Experimental	TreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days. Receives: Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Atorvastatin and Fenofibric acid AUCτ
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
Measured: 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
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
Measured: 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 outcomes (4)

Atorvastatin and Fenofibric acid Css,min
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
Measured: 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
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
Measured: 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
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
Measured: 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
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 201530 Apr 2015

First posted21 Apr 2015 (estimated)
Study start17 Mar 2015
Primary completion22 Mar 2015
Study completion30 Apr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02422030
Sponsor's protocol ID: 146DDI14030
Status last verified: Mar 2015
First submitted: 25 Mar 2015
Last updated: 8 Aug 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02422030
Acronym / sponsor ID: 146DDI14030
Conditions: Healthy
Keywords: Male Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 17 Mar 2015 (actual)
Primary completion: 22 Mar 2015 (actual)
Study completion: 30 Apr 2015 (actual)
First posted: 21 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Group1: TreatmentA+TreatmentB+TreatmentC	Experimental	Drug: Lipitor Tab. 40mg, Drug: Trilipix 135mgTreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Group2: TreatmentC+TreatmentA+TreatmentB	Experimental	Drug: Lipitor Tab. 40mg, Drug: Trilipix 135mgTreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Group3: TreatmentB+TreatmentC+TreatmentA	Experimental	Drug: Lipitor Tab. 40mg, Drug: Trilipix 135mgTreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Group4: TreatmentC+TreatmentB+TreatmentA	Experimental	Drug: Lipitor Tab. 40mg, Drug: Trilipix 135mgTreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Group5: TreatmentB+TreatmentA+TreatmentC	Experimental	Drug: Lipitor Tab. 40mg, Drug: Trilipix 135mgTreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days.
Group6: TreatmentA+TreatmentC+TreatmentB	Experimental	Drug: Lipitor Tab. 40mg, Drug: Trilipix 135mgTreatmentA: Atorvastatin 40m1T/day, TreatmentB: Fenofibric acid 135mg1Cap/day, TreatmentC: Atorvastatin 40m1T/day and Fenofibric acid 135mg1Cap/day. Each treatment period was separated by a washout period of at least 8days.

Who may qualify

Ages: 19 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (21 listed)

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)
Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
Showing the value that corresponds to following laboratory parameters: AST or AST or CK > 2* upper limit of normal range.
Alcohol > 210g/week, within 6 months prior to the screening.
Taking the medication involved in other clinical trials within two months before the first dose medication characters.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lipitor Tab. 40mgAlso: Atorvastatin 40mg	Drug	Group1: TreatmentA+TreatmentB+TreatmentC, Group2: TreatmentC+TreatmentA+TreatmentB, Group3: TreatmentB+TreatmentC+TreatmentA, Group4: TreatmentC+TreatmentB+TreatmentA, Group5: TreatmentB+TreatmentA+TreatmentC, Group6: TreatmentA+TreatmentC+TreatmentB
Trilipix 135mgAlso: Fenofibric acid 135mg	Drug	Group1: TreatmentA+TreatmentB+TreatmentC, Group2: TreatmentC+TreatmentA+TreatmentB, Group3: TreatmentB+TreatmentC+TreatmentA, Group4: TreatmentC+TreatmentB+TreatmentA, Group5: TreatmentB+TreatmentA+TreatmentC, Group6: TreatmentA+TreatmentC+TreatmentB

Primary outcome

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
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

4 secondary outcomes

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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.

Related trials for Healthy

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Min Gul Kim principal investigator

Chonbuk National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lipitor Tab. 40mg and Trilipix 135mg in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02422030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.