Bioavailability of Omega-3 Food Supplement in Healthy Subjects

Biological Availability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376608
• Other study ID #: CTN00714101
• Status: Completed
• Phase: Phase 1
• First received: February 10, 2015
• Last updated: February 25, 2015
• Start date: August 2014
• Est. completion date: September 2014

Study information

• Verified date: August 2014
• Source: Pronova BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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• earlier participated in or withdrawn from the study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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Biological Availability

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
United Kingdom	Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Pronova BioPharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under curve of omega-3 food supplements under light fed conditions in healthy subjects.		Pharmacikinetics up to 36 hours post-dose	Yes
Primary	Peak plasma concentration of omega-3 food supplements under light fed conditions in healthy subjects.		Pharmacikinetics up to 36 hours post-dose	Yes
Secondary	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.	Yes