NCT02376621

Bioavailability of Omega-3 Food Supplements in Healthy Subjects

Nutrition Products - An Open-Label, Randomised, Single-Dose Study to Evaluate the Bioavailability of Omega-3 Based Dietary Supplements Under Fasting Conditions in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pronova BioPharma · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted conditions in healthy adult subjects. Each subject will participate in 5 treatment periods. The order of treatments will be in accordance with the randomisation schedule.There will be a minimum of 4 treatment-free days between each treatment period. On each dosing occasion, subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing. Twenty-four subjects will be enrolled to complete dosing of 20 subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PronovaPure 150:500 triglycerides	Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
DIETARY_SUPPLEMENT	Pronovum PRF-048	Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
DIETARY_SUPPLEMENT	Pronovum PRF-037	Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
DIETARY_SUPPLEMENT	PronovaPure 500:200 TG	Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
DIETARY_SUPPLEMENT	Pronovum PRF-047	Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2015-03-03
• Last updated: 2015-03-03

Locations

1 site across 1 country: United Kingdom