Bioavailability of Omega-3 Food Supplement in Healthy Subjects

Pronovum - An Open-label, Randomized, Single-dose Study to Evaluate the Bioavailability of Omega-3 Food Supplements in Healthy Male and Female Subjects.

The study will evaluate the relative bioavailability of Pronovum PRF-037 and Pronovum PRF-041 with PronovaPure 150:150 EE EU and Eskimo-3 (500 mg omega-3 acid triglyceride containing 80 mg EPA and 50 mg DHA per gram oil) in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Biological Availability
• Intervention / Treatment: Dietary supplement: Pronova Pure 150:500 EE EU; Dietary supplement: Pronovum PRF-037; Dietary supplement: Pronovum PRF-041; Dietary supplement: Eskimo-3

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• males or females
• any ethnic origin
• BMI 18.5 - 30.0 kg/m2
• generally in good health
• signed informed consent

Exclusion Criteria:

• males or females not willing to use appropriate contraception
• prescribed systemic or topical medication within 14 days and slow release medication considered to be active within 14 days.
• omega-3 fatty acids or fish oil within 2 weeks of dosing.
• any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days
• any medication incl. St.John's Worth known to chronically alter drug absorption/elimination within 30 days
• Subjects still present in clinical study or in the past 3 months
• recent blood donation
• drug allergy or significant allergic disease
• allergic or hypersensitivity to omega-3 acids, fish, soya, oleic acid, sesame oil or other constituents in pharma preparation
• high consumption of alcohol
• high consumption of tobacco
• hepatitis or HIV
• vegetarians
• earlier participated in or withdrawn from the study
• not willing to follow dietary restrictions
• frequent occurence of migraine attacks
• subjects that should not participate according to investigator

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pronova Pure 150:500 EE EU; 2 × PronovaPure 150:500 EE EU	Dietary supplement: Pronova Pure 150:500 EE EU; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Pronovum PRF-037; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Pronovum PRF-041; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Eskimo-3; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Active Comparator: Pronovum PRF-037; 2 × Pronovum PRF-037	Dietary supplement: Pronova Pure 150:500 EE EU; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Pronovum PRF-037; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Pronovum PRF-041; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Eskimo-3; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Active Comparator: Pronovum PRF-041; 2 × Pronovum PRF-041	Dietary supplement: Pronova Pure 150:500 EE EU; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Pronovum PRF-037; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Pronovum PRF-041; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Eskimo-3; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Active Comparator: Eskimo-3; 3 × Eskimo-3	Dietary supplement: Pronova Pure 150:500 EE EU; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Pronovum PRF-037; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Pronovum PRF-041; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period; Dietary supplement: Eskimo-3; Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under curve of omega-3 food supplements under light fed conditions in healthy subjects.	Pharmacikinetics up to 36 hours post-dose
Peak plasma concentration of omega-3 food supplements under light fed conditions in healthy subjects.	Pharmacikinetics up to 36 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events as a measure of safety and tolerability.	During entire study period, an expected average of 7 weeks from screening to last visit.

Collaborators and Investigators

• Sponsor: Pronova BioPharma
• Investigators: Principal Investigator: Adam Strong, MD, Covance Clinical Research Unit (CRU) Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Estimate): March 3, 2015
• Last Update Submitted That Met QC Criteria: February 25, 2015
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CTN00714101