Healthy Male VolunteersPhase 1NCT01767610
Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin
A Phase 1 study testing micronized fenofibrate 160mg, pitavastatin Ca 2mg and micronized fenofibrate 160mg plus pitavastatin Ca 2mg in people with Healthy Male Volunteers, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap. 160mg and Livalo tab. 2mg through 3 period by separately or combinedly. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- micronized fenofibrate 160mg, pitavastatin Ca 2mg and micronized fenofibrate 160mg plus pitavastatin Ca 2mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Jul 2013
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Years 20-55
- Body weight≥50kg and 18≤BMI≤29kg/m2
- Volunteer
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, 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 albe 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.
About this study
Official title: Open-label, Randomized, Repeated Dosing Crossover Study to Evaluate the Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin in Healthy Adult Subjects
To evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap. 160mg and Livalo tab. 2mg through 3 period by separately or combinedly.
Read the detailed description
To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap. 160mg(micronized fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong Wae Pharm. through 3 period by separately or combinedly.
- Conditions
- Healthy Male Volunteers
- Being tested
- micronized fenofibrate 160mg, pitavastatin Ca 2mg, micronized fenofibrate 160mg plus pitavastatin Ca 2mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronized fenofibrate 160mgDrug
Also called Lipilfen cap. 160mg : once daily for 5 days
pitavastatin Ca 2mgDrug
Also called Livalo tab. 2mg : once daily for 5 days
micronized fenofibrate 160mg plus pitavastatin Ca 2mgDrug
Also called Lipilfen cap. 160mg plus Livalo tab. 2mg : once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| micronized fenofibrate | Experimental | Not described Receives: Drug: micronized fenofibrate 160mg |
| pitavastatin Ca | Experimental | Not described Receives: Drug: pitavastatin Ca 2mg |
| micronized fenofibrate plus pitavastatin Ca | Experimental | Not described Receives: Drug: micronized fenofibrate 160mg plus pitavastatin Ca 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-Drug interaction evaluation (Cmax,ss, Cmin,ss, Tmax,ss)
Measured: just before dosing on 1st day and 4th day of each period and 0, 0.25, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48hr on final 5th dosing
Secondary outcomes (1)
Number of participants with adverse events
Measured: Participants will be followed for the duration of study medication dosing days and hospital stay, and expected average of 3days and follow-up 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.
- First posted14 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767610
- Sponsor's protocol ID
- HL-PIF-101
- Status last verified
- Aug 2018
- First submitted
- 11 Jan 2013
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Repeated Dosing Crossover Study to Evaluate the Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01767610
- Acronym / sponsor ID
- HL-PIF-101
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Jan 2013 (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.
To evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap. 160mg and Livalo tab. 2mg through 3 period by separately or combinedly.
Detailed description
To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap. 160mg(micronized fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong Wae Pharm. through 3 period by separately or combinedly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| micronized fenofibrate | Experimental | Drug: micronized fenofibrate 160mg |
| pitavastatin Ca | Experimental | Drug: pitavastatin Ca 2mg |
| micronized fenofibrate plus pitavastatin Ca | Experimental | Drug: micronized fenofibrate 160mg plus pitavastatin Ca 2mg |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Years 20-55
- Body weight≥50kg and 18≤BMI≤29kg/m2
- Volunteer
Key exclusion criteria (19 listed)
- 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
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 |
|---|---|---|
| micronized fenofibrate 160mgAlso: Lipilfen cap. 160mg : once daily for 5 days | Drug | micronized fenofibrate |
| pitavastatin Ca 2mgAlso: Livalo tab. 2mg : once daily for 5 days | Drug | pitavastatin Ca |
| micronized fenofibrate 160mg plus pitavastatin Ca 2mgAlso: Lipilfen cap. 160mg plus Livalo tab. 2mg : once daily for 5 days | Drug | micronized fenofibrate plus pitavastatin Ca |
Primary outcome
Drug-Drug interaction evaluation (Cmax,ss, Cmin,ss, Tmax,ss)
Time frame: just before dosing on 1st day and 4th day of each period and 0, 0.25, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48hr on final 5th dosing
1 secondary outcome
Number of participants with adverse events
Time frame: Participants will be followed for the duration of study medication dosing days and hospital stay, and expected average of 3days and follow-up period for maximum 7 days from the discharge
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 3 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 micronized fenofibrate 160mg, pitavastatin Ca 2mg and micronized fenofibrate 160mg plus pitavastatin Ca 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 3 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?
Drug-Drug interaction evaluation (Cmax,ss, Cmin,ss, Tmax,ss) (time frame: just before dosing on 1st day and 4th day of each period and 0, 0.25, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48hr on final 5th dosing). 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 3 Aug 2018.