Status:
COMPLETED
Bioavailability of EPA + DHA in a SMEDS Formulation
Lead Sponsor:
Midwest Center for Metabolic and Cardiovascular Research
Collaborating Sponsors:
Pharmavite LLC
Conditions:
Bioavailability
Eligibility:
All Genders
18-55 years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03443076
Start Date
February 16 2018
End Date
April 15 2018
Last Update
March 23 2023
Active Locations (2)
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1
MB Clinical Research, LLC
Boca Raton, Florida, United States, 33487
2
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640