BioavailabilityNCT03443076
Bioavailability of EPA + DHA in a SMEDS Formulation
A study testing EPA + DHA in SMEDS Formulation and Lovaza (active comparator; already FDA approved) in people with Bioavailability, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites in United States.
Trial summary
This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation compared with a standard omega-3-acid ethyl ester product in healthy men and women. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- EPA + DHA in SMEDS Formulation and Lovaza (active comparator; already FDA approved)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Feb 2018to 15 Apr 2018
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 18.50-29.99 kg/m2
- Good health on basis of medical history and routine laboratory tests
- Score of at least 7 on vein access scale
- Willing and able to remain at site for extended testing periods, including a total of 4 overnight stays, and to consume foods and products provided by study staff on those days
- Willing to abstain from alcohol for 24 h prior to clinic admission
- No plans to change smoking habits or other nicotine use
- Willing to undergo 13 venipunctures during each treatment period
Who cannot join
- Screening lab test of clinical significance
- Positive urine drug screen
- Clinically significant endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, gastrointestinal or biliary disorder
- Uncontrolled hypertension
- Recent history or presence of cancer
- Difficulty swallowing capsules
Show all 12Show fewer
- Recent blood donation or blood loss
- Recent consumption of high-dose fish oil or fish
- Recent use of any prescribed medication or over-the-counter medicinal products, including herbal or dietary supplements (except daily omega-3 fatty acid-free vitamin and/or mineral supplement or occasional use of acetaminophen or non-steroidal anti-inflammatory drugs)
- Signs or symptoms of active infection or has recently taken antibiotics
- Recent history or strong potential for drug or alcohol abuse
- Pregnant, planning to be pregnant during the study, lactating or of childbearing potential and unwilling to commit to use of a medically approved form of contraception throughout the study (note: hormonal contraceptive use is not allowed)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MB Clinical Research, LLC
Boca Raton, Florida, 33487
Great Lakes Clinical Trials
Chicago, Illinois, 60640
About this study
Official title: A Randomized, Crossover Study to Assess the Relative Bioavailability of Eicosapentaenoic Acid and Docosahexaenoic Acid in a Self-micro-emulsifying Delivery System (SMEDS) Formulation Compared With a Standard Omega-3-acid Ethyl Ester Product
This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation compared with a standard omega-3-acid ethyl ester product in healthy men and women.
- Conditions
- Bioavailability
- Being tested
- EPA + DHA in SMEDS Formulation, Lovaza (active comparator; already FDA approved)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA + DHA in SMEDS FormulationDietary supplement
A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation
Lovaza (active comparator; already FDA approved)Other
A single dose of 840 mg EPA + DHA administered as Lovaza. This intervention was used as an active comparator in this study. Lovaza was already FDA-approved when the study was conducted.
| Study group | Role | What they receive |
|---|---|---|
| EPA + DHA in SMEDS Formulation | Experimental | Subject will receive a single 500 mg oral dose of EPA + DHA in a SMEDS formulation Receives: Dietary Supplement: EPA + DHA in SMEDS Formulation |
| EPA + DHA (Lovaza) | Active comparator | Subject will receive a single 840 mg oral dose of EPA + DHA as Lovaza Receives: Other: Lovaza (active comparator; already FDA approved) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours
Measured: 0-24 h on Days 0-1 and on Days 14-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start16 Feb 2018
- Primary completion5 Apr 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BioavailabilityStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmavite LLC
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, PhD, Study director, Midwest Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443076
- Sponsor's protocol ID
- MB-1705
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2018
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maki KC, Palacios OM, Buggia MA, Trivedi R, Dicklin MR, Maki CE. Effects of a Self-micro-emulsifying Delivery System Formulation Versus a Standard omega-3 Acid Ethyl Ester Product on the Bioavailability of Eicosapentaenoic Acid and Docosahexaenoic Acid: A Study in Healthy Men and Women in a Fasted State. Clin Ther. 2018 Dec;40(12):2065-2076. doi: 10.1016/j.clinthera.2018.10.014. Epub 2018 Nov 16.
PubMed 30454850
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Study to Assess the Relative Bioavailability of Eicosapentaenoic Acid and Docosahexaenoic Acid in a Self-micro-emulsifying Delivery System (SMEDS) Formulation Compared With a Standard Omega-3-acid Ethyl Ester Product
- ClinicalTrials.gov ID
- NCT03443076
- Acronym / sponsor ID
- MB-1705
- Conditions
- Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Pharmavite LLC
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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.
This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation compared with a standard omega-3-acid ethyl ester product in healthy men and women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPA + DHA in SMEDS Formulation | Experimental | Dietary Supplement: EPA + DHA in SMEDS FormulationSubject will receive a single 500 mg oral dose of EPA + DHA in a SMEDS formulation |
| EPA + DHA (Lovaza) | Active comparator | Other: Lovaza (active comparator; already FDA approved)Subject will receive a single 840 mg oral dose of EPA + DHA as Lovaza |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body mass index 18.50-29.99 kg/m2
- Good health on basis of medical history and routine laboratory tests
- Score of at least 7 on vein access scale
- Willing and able to remain at site for extended testing periods, including a total of 4 overnight stays, and to consume foods and products provided by study staff on those days
- Willing to abstain from alcohol for 24 h prior to clinic admission
Key exclusion criteria (12 listed)
- Screening lab test of clinical significance
- Positive urine drug screen
- Clinically significant endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, gastrointestinal or biliary disorder
- Uncontrolled hypertension
- Recent history or presence of cancer
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 |
|---|---|---|
| EPA + DHA in SMEDS FormulationA single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation | Dietary supplement | EPA + DHA in SMEDS Formulation |
| Lovaza (active comparator; already FDA approved)A single dose of 840 mg EPA + DHA administered as Lovaza. This intervention was used as an active comparator in this study. Lovaza was already FDA-approved when the study was conducted. | Other | EPA + DHA (Lovaza) |
Primary outcome
Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours
Time frame: 0-24 h on Days 0-1 and on Days 14-15
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 23 Mar 2023.
- Derived from this study: PubMed 30454850Maki KC, Palacios OM, Buggia MA, Trivedi R, Dicklin MR, Maki CE. Effects of a Self-micro-emulsifying Delivery System Formulation Versus a Standard omega-3 Acid Ethyl Ester Product on the Bioavailability of Eicosapentaenoic Acid and Docosahexaenoic Acid: A Study in Healthy Men and Women in a Fasted State. Clin Ther. 2018 Dec;40(12):2065-2076. doi: 10.1016/j.clinthera.2018.10.014. Epub 2018 Nov 16.
- Individual participant dataSharing planned: No
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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.
Kevin C Maki, PhD study director
Midwest Biomedical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA + DHA in SMEDS Formulation and Lovaza (active comparator; already FDA approved) in people with Bioavailability, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites in United States.
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 7 inclusion and 12 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours (time frame: 0-24 h on Days 0-1 and on Days 14-15). 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 NCT03443076, which also lists 1 linked publication.
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 23 Mar 2023.