Bioavailability of EPA + DHA in a SMEDS Formulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-16

Study Completion Date

2018-04-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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EPA + DHA in SMEDS Formulation

Subject will receive a single 500 mg oral dose of EPA + DHA in a SMEDS formulation

Group Type EXPERIMENTAL

EPA + DHA in SMEDS Formulation

Intervention Type DIETARY_SUPPLEMENT

A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation

EPA + DHA (Lovaza)

Subject will receive a single 840 mg oral dose of EPA + DHA as Lovaza

Group Type ACTIVE_COMPARATOR

Lovaza (active comparator; already FDA approved)

Intervention Type 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.

Interventions

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EPA + DHA in SMEDS Formulation

A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes