Bioavailability of EPA + DHA in a SMEDS Formulation

• Status: Completed
• Trial end date: 2018-04-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Midwest Center for Metabolic and Cardiovascular Research
• Collaborators: Pharmavite; Pharmavite LLC

Criteria

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)