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NCT05394701
Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids
NA trial testing Omega-3 LipoMicel® soft gels in Pharmacokinetics in 12 participants. Completed in 31 December 2022.
31 December 2022
Quick facts
| Lead sponsor | Factors Group of Nutritional Companies Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 March 2022 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Omega-3 LipoMicel® soft gels
- RxOmega-3 soft gels (Enteric)
- Omega-3 Complete soft gels (Non-Enteric)
Conditions studied
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
Factors Group of Nutritional Companies Inc. — full company profile →
Who can join
Adults 21 to 65, any sex, with Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this study is to investigate the uptake/gastrointestinal absorption of fatty acids in healthy adult volunteers by using enteric coated and non-enteric coated soft capsules containing omega 3 fatty acids. Pharmacokinetic parameters such as AUC and Cmax, as well as any adverse events are recorded. As secondary objective, the short-term effects of Omega-3 supplementation on blood lipid parameters in healthy volunteers are evaluated using a Cholestech LDX analyzer to measure cholesterol and related lipids.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluation of the Metabolite Profile of Fish Oil Omega-3 Fatty Acids (n-3 FAs) in Micellar and Enteric-Coated Forms-A Randomized, Cross-Over Human Study.
Ibi A, Chang C, Kuo YC, Zhang Y, et al · · 2024 · cited 5× · PMID 38786742 · DOI 10.3390/metabo14050265
Verify or expand the search:
- PubMed search for NCT05394701
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05394701 (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 Factors Group of Nutritional Companies Inc.
- Last refreshed: 13 September 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/NCT05394701.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing