Bioavailability
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTEPA + DHA in SMEDS Formulation
A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation
OTHERLovaza (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.
Sponsors
Pharmavite LLC
Midwest Center for Metabolic and Cardiovascular Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed