Trials / Completed
CompletedNCT05394701
Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids
Comparing the Pharmacological Profile of Enteric Coated and Non-Enteric Coated Capsules Containing Omega 3 Fatty Acids
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Factors Group of Nutritional Companies Inc. · Industry
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Omega-3 LipoMicel® soft gels | A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) |
| DIETARY_SUPPLEMENT | RxOmega-3 soft gels (Enteric) | A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) |
| DIETARY_SUPPLEMENT | Omega-3 Complete soft gels (Non-Enteric) | A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) |
Timeline
- Start date
- 2022-03-01
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2022-05-27
- Last updated
- 2023-09-13
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05394701. Inclusion in this directory is not an endorsement.