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AzTrials

Healthy Male VolunteersPhase 1NCT02250976

The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca

A Phase 1 study testing Livasupril Cap.160/2mg, Lipilfen cap. 160mg and Livaro tab. 2mg in people with Healthy Male Volunteers, run by Hanlim Pharm. Co., Ltd. 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
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Trial summary

To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers. 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
Healthy Male Volunteers
What is being tested?
Livasupril Cap.160/2mg, Lipilfen cap. 160mg and Livaro tab. 2mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteSouth Korea
Study dates
Sep 2014to Oct 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

  • Healthy male subjects age 19 to 55 at the screening visit
  • Body weight≥50kg and within Ideal body weight±20%
  • Subject who is judged to be eligible according to clinical laboratory tests including hematological examination, blood chemistry examination, urine analysis
  • Subject who volunteerly determined to participate in and agreed to comply with precautions after totally understand the detailed explanations about this study

Who cannot join

  • Subject with serious active cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
  • Subject with symptoms of acute disease within 28days prior to study medication dosing
  • Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug
  • Subject with clinically significant active chronic disease
  • Subject with any of the following conditions in laboratory test i. AST(aspartate aminotransferase) or ALT(alanine transferase) > upper normal limit × 1.5 ii. Total bilirubin > upper normal limit × 1.5 iii. renal failure with Creatinine clearance < 50mL/min iv. creatine phosphokinase > upper normal limit × 2
  • Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, human immunodeficiency virus antigen/antibody,venereal disease research laboratory test
Show all 19Show fewer
  • Use of any prescription medication within 14 days prior to study medication dosing
  • Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
  • Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
  • Subject with known for hypersensitivity reaction to fenofibrate, fenofibric acid or statin
  • gallbladder disease
  • Subject who experiences photo-allergy or photo-toxicity during administrating fibrates or ketoprofen
  • Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
  • Subject who is not able to taking the institutional standard meal
  • Subject with whole blood donation within 60days, component blood donation within 20days
  • Subjects receiving blood transfusion within 30days prior to study medication dosing
  • Participation in any clinical investigation within 60days prior to study medication dosing
  • Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day)
  • Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyungpook National University Hospital

    Daegu, 700-721

Other trials in South Korea

About this study

Official title: A Clinical Trial to Evaluate the Pharmacokinetics of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca Under Fed Condition in Healthy Male Volunteers

To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.

Read the detailed description

To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.

Being tested
Livasupril Cap.160/2mg, Lipilfen cap. 160mg, Livaro tab. 2mg

What participants receive

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

  • Livasupril Cap.160/2mgDrug

    Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg

  • Lipilfen cap. 160mgDrug

    Micronized fenofibrate 160mg

  • Livaro tab. 2mgDrug

    Pitavastatin Ca 2mg

Study groups in NCT02250976
Study groupRoleWhat they receive
Livasupril Cap.160/2mgExperimental* Fenofibrate pellet ( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg * once a day
Receives: Drug: Livasupril Cap.160/2mg
Lipilfen cap.160mg, Livaro tab. 2mgActive comparator* Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg * Coadministariton of Lipilfen cap.160mg and Livaro tab. 2mg, once a day
Receives: Drug: Lipilfen cap. 160mg; Drug: Livaro tab. 2mg

What is being measured

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

  1. AUClast(area under the curve) of fenofibric acid

    Measured: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)

  2. Cmax(maximum concentration) of fenofibric acid

    Measured: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)

  3. AUClast(area under the curve) of pitavastatin

    Measured: Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)

  4. Cmax(maximum concentration) of pitavastatin

    Measured: Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)

Secondary outcomes (7)

  1. AUCinf(area under the curve) of fenofibric acid

    Measured: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)

  2. Tmax(time to Maximum Plasma Concentration) of fenofibric acid

    Measured: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)

  3. t1/2(half life) of fenofibric acid

    Measured: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)

  4. AUCinf(area under the curve) of pitavastatin

    Measured: Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)

  5. Tmax(time to Maximum Plasma Concentration) of pitavastatin

    Measured: Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)

  6. t1/2(half life) of pitavastatin

    Measured: Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)

  7. Number of participants with adverse events

    Measured: Participants will be followed for the duration of hospital stay, and expected period for maximum 7 days from the discharge

Timeline

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

  1. First posted26 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02250976
Sponsor's protocol ID
HL-PIF-103
Status last verified
Aug 2018
First submitted
23 Sep 2014
Last updated
3 Aug 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Livasupril Cap.160/2mg, Lipilfen cap. 160mg and Livaro tab. 2mg in people with Healthy Male Volunteers, run by Hanlim Pharm. Co., Ltd. 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 3 Aug 2018. 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?

AUClast(area under the curve) of fenofibric acid (time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)). The study lists 4 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 NCT02250976.

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 3 Aug 2018.

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