HealthyPhase 1NCT00960687
Fed Bioequivalence Study of Fenofibric Acid Versus TriCor® (Fenofibrate)
A Phase 1 study testing Fenofibric Acid (Fibricor™) 105 mg Tablet and Fenofibrate (Tricor®) 145 mg Tablet in people with Healthy, run by Mutual Pharmaceutical Company, Inc..
Trial summary
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Safety and tolerability of this regimen will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fenofibric Acid (Fibricor™) 105 mg Tablet and Fenofibrate (Tricor®) 145 mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Nov 2007
- 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
- Healthy adults 18-45 years of age
- Non-smoking
- Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
- Body mass index (BMI) less than 30
- Medically healthy on the basis of medical history and physical examination
- Hemoglobin > or = to 12g/dL
- Completion of the screening process within 28 days prior to dosing
- Provision of voluntary written informed consent
Who cannot join
- Recent participation (within 28 days) in other research studies
- Recent significant blood donation or plasma donation
- Pregnant or lactating
- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
- Recent (2-year) history or evidence of alcoholism or drug abuse
- History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
- Drug allergies to fenofibrate (fenofibric acid)
About this study
Official title: A Single-Dose, Bioequivalence Study of 105 mg Fenofibric Acid Tablets Versus 145 mg TriCor® (Fenofibrate) Tablets Under Fed Conditions(Standard Meal)
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Safety and tolerability of this regimen will also be evaluated.
Read the detailed description
Fenofibrate is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. The primary objective of this study is to evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Additionally, the safety and tolerability of this dosing regimen will be evaluated. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of two dosing regimens (fenofibric acid and fenofibrate) in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, subjects will receive either a single oral dose of the test formulation, fenofibric acid (1 x 105 mg tablet) or a single oral dose of the reference formulation, fenofibrate (1 x 145 mg tablet) 30 minutes after the initiation of a standard breakfast. After a 7 day washout period, on the morning of Day 8, subjects will receive the alternate regimen 30 minutes after the initiation of a standard breakfast. Fasting will continue for 4 hours after each dose. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid. Subjects will be monitored throughout their participation for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured prior to each dose and approximately 2 hours post-dose. All adverse experiences, whether elicited by query, spontaneously reported, or observed by clinic staff, will be documented in the subject's case report form.
- Conditions
- Healthy
- Being tested
- Fenofibric Acid (Fibricor™) 105 mg Tablet, Fenofibrate (Tricor®) 145 mg Tablet
- Keywords
- healthy, pharmacokinetics, therapeutic equivalency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibric Acid (Fibricor™) 105 mg TabletDrug
Also called Fibricor™
1 x 105 mg fenofibric acid (Fibricor™) tablet administered 30 minutes after the initiation of a standard breakfast.
Fenofibrate (Tricor®) 145 mg TabletDrug
Also called Tricor®
1 x 145 mg Fenofibrate (Tricor®) tablet administered 30 minutes after the start of a standard breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Fenofibric Acid (Fibricor™) | Experimental | 1 x 105 mg fenofibric acid (Fibricor™)tablet administered 30 minutes after the initiation of a standard breakfast. Receives: Drug: Fenofibric Acid (Fibricor™) 105 mg Tablet |
| Fenofibrate (Tricor®) | Experimental | 1 x 145 mg fenofibrate (Tricor®) tablet administered 30 minutes after the initiation of a standard breakfast. Receives: Drug: Fenofibrate (Tricor®) 145 mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that the drug reaches in the plasma.
Measured: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
Measured: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Measured: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startOct 2007
- Primary completionNov 2007
- Study completionNov 2007
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anthony R Godfrey, Pharm. D., Principal investigator, PRACS Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960687
- Sponsor's protocol ID
- MPC-028-07-1008
- Other IDs
- R07-1033
- Status last verified
- Oct 2009
- First submitted
- 14 Aug 2009
- Last updated
- 20 Oct 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Bioequivalence Study of 105 mg Fenofibric Acid Tablets Versus 145 mg TriCor® (Fenofibrate) Tablets Under Fed Conditions(Standard Meal)
- ClinicalTrials.gov ID
- NCT00960687
- Acronym / sponsor ID
- MPC-028-07-1008
- Conditions
- Healthy
- Keywords
- healthy, pharmacokinetics, therapeutic equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Posted 14 Oct 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 evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Safety and tolerability of this regimen will also be evaluated.
Detailed description
Fenofibrate is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. The primary objective of this study is to evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Additionally, the safety and tolerability of this dosing regimen will be evaluated. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of two dosing regimens (fenofibric acid and fenofibrate) in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, subjects will receive either a single oral dose of the test formulation, fenofibric acid (1 x 105 mg tablet) or a single oral dose of the reference formulation, fenofibrate (1 x 145 mg tablet) 30 minutes after the initiation of a standard breakfast. After a 7 day washout period, on the morning of Day 8, subjects will receive the alternate regimen 30 minutes after the initiation of a standard breakfast. Fasting will continue for 4 hours after each dose. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid. Subjects will be monitored throughout their participation for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured prior to each dose and approximately 2 hours post-dose. All adverse experiences, whether elicited by query, spontaneously reported, or observed by clinic staff, will be documented in the subject's case report form.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenofibric Acid (Fibricor™) | Experimental | Drug: Fenofibric Acid (Fibricor™) 105 mg Tablet1 x 105 mg fenofibric acid (Fibricor™)tablet administered 30 minutes after the initiation of a standard breakfast. |
| Fenofibrate (Tricor®) | Experimental | Drug: Fenofibrate (Tricor®) 145 mg Tablet1 x 145 mg fenofibrate (Tricor®) tablet administered 30 minutes after the initiation of a standard breakfast. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adults 18-45 years of age
- Non-smoking
- Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
- Body mass index (BMI) less than 30
- Medically healthy on the basis of medical history and physical examination
Key exclusion criteria (8 listed)
- Recent participation (within 28 days) in other research studies
- Recent significant blood donation or plasma donation
- Pregnant or lactating
- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
- Recent (2-year) history or evidence of alcoholism or drug abuse
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 |
|---|---|---|
| Fenofibric Acid (Fibricor™) 105 mg TabletAlso: Fibricor™1 x 105 mg fenofibric acid (Fibricor™) tablet administered 30 minutes after the initiation of a standard breakfast. | Drug | Fenofibric Acid (Fibricor™) |
| Fenofibrate (Tricor®) 145 mg TabletAlso: Tricor®1 x 145 mg Fenofibrate (Tricor®) tablet administered 30 minutes after the start of a standard breakfast. | Drug | Fenofibrate (Tricor®) |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
The maximum or peak concentration that the drug reaches in the plasma.
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
Time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
Time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
- 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.
Anthony R Godfrey, Pharm. D. principal investigator
PRACS Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fenofibric Acid (Fibricor™) 105 mg Tablet and Fenofibrate (Tricor®) 145 mg Tablet in people with Healthy, run by Mutual Pharmaceutical Company, Inc..
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 8 inclusion and 8 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 20 Oct 2009. 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 14 Oct 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?
Maximum Plasma Concentration (Cmax) (time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.). The study lists 3 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 20 Oct 2009.