Bioavailability of EPA + DHA in a SMEDS Formulation

Study Overview
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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.

Official Title
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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

Conditions
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Bioavailability

Intervention / Treatment
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* Dietary Supplement: EPA + DHA in SMEDS Formulation
* Other: Lovaza (active comparator; already FDA approved)


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPA + DHA in SMEDS Formulation<br>Subject will receive a single 500 mg oral dose of EPA + DHA in a SMEDS formulation | Dietary Supplement: EPA + DHA in SMEDS Formulation<br>* A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation<br>|
| Active Comparator: EPA + DHA (Lovaza)<br>Subject will receive a single 840 mg oral dose of EPA + DHA as Lovaza | Other: Lovaza (active comparator; already FDA approved)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours |  | 0-24 h on Days 0-1 and on Days 14-15 |