Bioavailability study of Omega-3 Food Supplements
Research type
Research Study
Full title
Pronovum - An Open-Label, Randomised, Single-Dose Study to Evaluate the Bioavailability of Omega-3 Food Supplements in Healthy Male and Female Subjects
IRAS ID
160890
Contact name
Adam Strong
Contact email
Sponsor organisation
Pronova BioPharma Norge AS
Eudract number
2014-001883-36
Research summary
Pronovum capsules (The Investigational Food Supplements (IFS)) are soft gelatine capsules containing PronovaPure omega-3 concentrates which are derived from crude fish oil. A complex manufacturing process gives the food ingredient which contains 70-75% omega-3-acid EE. The Pronovum capsules are available in different formulations which differ in terms of choice of additives but contain PronovaPure 150:500 EE EU oil. And these are designed to have an improved absorption compared to other omega-3 fish oil products.
This study will evaluate the relative bioavailability (percentage absorbed in to blood stream) of the following in healthy male and female subjects:
PronovaPure (600 mg Omega-3-acid EE containing 150 mg EPA and 500 mg DHA per gram of oil)
Pronovum PRF-037 (600 mg Omega-3-acid EE containing 150 mg EPA and 500 mg DHA per gram of oil, excipients Tween 20 and Tween 80)
Promovum PRF-041 (600 mg Omega-3-acid EE containing 150 mg EPA and 500 mg DHA per gram of oil, excipients Tween 20 and Oleic acid)
Eskimo-3 (500 mg Omega-3-acidTG fish oil containing 80 mg EPA and 50 mg DHA per gram of oil)The study is open-label which is appropriate as the primary objective is to evaluate the bioavailability of omega-3 based food supplements under light fed conditions in healthy adult subjects.
A total of 24 healthy male and female subjects will be treated to complete 20 subjects. Each subject will receive 4 single oral dose administrations 30 minutes after starting a light breakfast. Subjects will be allocated 20 minutes to complete each meal. Each subject will participate in 4 treatment periods.
In first treatment period subjects will be residing at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 1 (approximately 16 hours postdose. Subjects will return to the CRU at 24 hours and 36 hours postdose for blood draw. During Treatment Periods 2, 3 and 4, subjects will return to the CRU on the morning of Day 1 and will be discharged from the CRU approximately 16 hours postdose. Subjects will return to the CRU at 24 hours and 36 hours postdose for pharmacokinetic (concentration in blood) assessments. There will be a minimum of 4 treatment-free days between each treatment period.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1344
Date of REC Opinion
11 Aug 2014
REC opinion
Favourable Opinion