Dyslipidemia (Fredrickson Type Ⅱa)Phase 1NCT02066207
CKD-337 Drug Interaction Study
A Phase 1 study testing Fenofibrate and Atorvastatin in people with Dyslipidemia (Fredrickson Type Ⅱa) and Dyslipidemia (Fredrickson Type Ⅱb), run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia (Fredrickson Type Ⅱa), Dyslipidemia (Fredrickson Type Ⅱb)
- What is being tested?
- Fenofibrate and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Mar 2014to 29 May 2014
- 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Fenofibrate, Atorvastatin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
AtorvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate | Experimental | Subjects received Fenofibrate Receives: Drug: Fenofibrate |
| Atorvastatin | Experimental | Subjects received Atorvastatin Receives: Drug: Atorvastatin |
| Fenofibrate and Atorvastatin | Experimental | Subjects received Fenofibrate and Atorvastatin Receives: Drug: Fenofibrate; Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt, Cmax,ss of fenofibric acid and atorvastatin
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h
Secondary outcomes (1)
Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study start18 Mar 2014
- Primary completion7 Apr 2014
- Study completion29 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyslipidemia (Fredrickson Type Ⅱa)Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wooseong Huh, M.D., Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066207
- Sponsor's protocol ID
- 146DDI13024
- Status last verified
- Mar 2014
- First submitted
- 16 Feb 2014
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Fenofibrate and Atorvastatin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02066207
- Acronym / sponsor ID
- 146DDI13024
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2014 (actual)
- Primary completion
- 7 Apr 2014 (actual)
- Study completion
- 29 May 2014 (actual)
- First posted
- 19 Feb 2014 (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 a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate | Experimental | Drug: FenofibrateSubjects received Fenofibrate |
| Atorvastatin | Experimental | Drug: AtorvastatinSubjects received Atorvastatin |
| Fenofibrate and Atorvastatin | Experimental | Drug: Fenofibrate, Drug: AtorvastatinSubjects received Fenofibrate and Atorvastatin |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| Fenofibrate | Drug | Fenofibrate, Fenofibrate and Atorvastatin |
| Atorvastatin | Drug | Atorvastatin, Fenofibrate and Atorvastatin |
Primary outcome
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
1 secondary outcome
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
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.
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.
Wooseong Huh, M.D., Ph.D. principal investigator
Samsung Medical Center
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 Fenofibrate and Atorvastatin in people with Dyslipidemia (Fredrickson Type Ⅱa) and Dyslipidemia (Fredrickson Type Ⅱb), 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 4 inclusion and 19 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 2 Nov 2026.