DyslipidemiaPhase 1NCT00928694
Fenofibrate Bioequivalence Study (0767-031)
A Phase 1 study testing fenofibrate (U.S. formulation) and fenofibrate (UK formulation) in people with Dyslipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- fenofibrate (U.S. formulation) and fenofibrate (UK formulation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Apr 2004
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is in good health
- Subject is willing to follow all study guidelines
Who cannot join
- Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe
- Female subject is receiving oral contraceptives or hormone replacement therapy
About this study
Official title: An Open-Label, Randomized, 2-Period, Crossover Study to Determine Definitive Bioequivalence After Administration of Single 160 mg Doses of the U.S. and UK Formulations of Fenofibrate in Healthy Adult Subjects
This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.
- Conditions
- Dyslipidemia
- Being tested
- fenofibrate (U.S. formulation), fenofibrate (UK formulation)
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenofibrate (U.S. formulation)Drug
Also called Tricor®
Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.
fenofibrate (UK formulation)Drug
Also called Supralip®
Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Fenofibrate U.S. Formulation Receives: Drug: fenofibrate (U.S. formulation) |
| 2 | Active comparator | Fenofibrate UK Formulation Receives: Drug: fenofibrate (UK formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid
Measured: Predose and up to 168 hours postdose
Maximum Plasma Concentration (Cmax) of Fenofibric Acid
Measured: Predose and up to 168 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startFeb 2003
- Primary completionApr 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928694
- Sponsor's protocol ID
- 0767-031
- Other IDs
- MK0767-031, 2009_606
- Status last verified
- Aug 2015
- First submitted
- 25 Jun 2009
- Last updated
- 19 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 2-Period, Crossover Study to Determine Definitive Bioequivalence After Administration of Single 160 mg Doses of the U.S. and UK Formulations of Fenofibrate in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00928694
- Acronym / sponsor ID
- 0767-031
- Conditions
- Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 11 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: fenofibrate (U.S. formulation)Fenofibrate U.S. Formulation |
| 2 | Active comparator | Drug: fenofibrate (UK formulation)Fenofibrate UK Formulation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject is in good health
- Subject is willing to follow all study guidelines
Key exclusion criteria (2 listed)
- Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe
- Female subject is receiving oral contraceptives or hormone replacement therapy
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 (U.S. formulation)Also: Tricor®Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods. | Drug | 1 |
| fenofibrate (UK formulation)Also: Supralip®Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods. | Drug | 2 |
Primary outcome
Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid
Time frame: Predose and up to 168 hours postdose
Maximum Plasma Concentration (Cmax) of Fenofibric Acid
Time frame: Predose and up to 168 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fenofibrate (U.S. formulation) and fenofibrate (UK formulation) in people with Dyslipidemia, run by Merck Sharp & Dohme LLC.
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 2 inclusion and 2 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid (time frame: Predose and up to 168 hours postdose). 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?
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 19 Aug 2015; AzTrials last refreshed its copy on 3 Nov 2026.