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NCT03443076
Bioavailability of EPA + DHA in a SMEDS Formulation
NA trial testing EPA + DHA in SMEDS Formulation in Bioavailability in 24 participants. Completed in 15 April 2018.
5 April 2018
Quick facts
| Lead sponsor | Midwest Center for Metabolic and Cardiovascular Research |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 24 |
| Start date | 16 February 2018 |
| Primary completion | 5 April 2018 |
| Estimated completion | 15 April 2018 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- EPA + DHA in SMEDS Formulation
- Lovaza (active comparator; already FDA approved)
Conditions studied
- Bioavailability — all drugs for Bioavailability →
Sponsor
Midwest Center for Metabolic and Cardiovascular Research
Who can join
Adults 18 to 55, any sex, with Bioavailability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effects of a Self-micro-emulsifying Delivery System Formulation Versus a Standard ω-3 Acid Ethyl Ester Product on the Bioavailability of Eicosapentaenoic Acid and Docosahexaenoic Acid: A Study in Healthy Men and Women in a Fasted State.
Maki KC, Palacios OM, Buggia MA, Trivedi R, et al · · 2018 · cited 13× · PMID 30454850 · DOI 10.1016/j.clinthera.2018.10.014
Verify or expand the search:
- PubMed search for NCT03443076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bioavailability
Currently open trials in the same condition.
- NCT07063173 — Bioavailability of Ration Items Containing Tart Cherry Extract · NA · recruiting
- NCT05774704 — Curcumin and Retinal Study · Phase 1, PHASE2 · recruiting
Other Midwest Center for Metabolic and Cardiovascular Research trials
Trials by the same sponsor.
- NCT07293091 — Assessing the Appearance of Amino Acids in Circulation Following Consumption of Protein Beverages · NA · completed
- NCT07012317 — A Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications · NA · completed
- NCT06923332 — A Trial to Assess the Effects of Diets With and Without Inulin on Energy Expenditure in Adults. · NA · completed
- NCT06494449 — Effect of Acute Intake of Meals Containing Higher vs. Lower Energy From Protein on DIT · NA · completed
- NCT06269094 — A Study to Understand How Continuous Glucose Monitors Impact Eating Behavior · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03443076 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Midwest Center for Metabolic and Cardiovascular Research
- Last refreshed: 23 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03443076.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing