Biological AvailabilityPhase 1NCT02376608

Bioavailability of Omega-3 Food Supplement in Healthy Subjects

A Phase 1 study testing Pronova Pure 150:500 EE EU, Pronovum PRF-037 and Pronovum PRF-041 in people with Biological Availability, run by Pronova BioPharma at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Biological Availability
What is being tested?: Pronova Pure 150:500 EE EU, Pronovum PRF-037 and Pronovum PRF-041
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2014to Sep 2014
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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earlier participated in or withdrawn from the study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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

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

Other trials in United Kingdom

About this study

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.

Conditions: Biological Availability
Being tested: Pronova Pure 150:500 EE EU, Pronovum PRF-037, Pronovum PRF-041, Eskimo-3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pronova Pure 150:500 EE EUDietary supplement
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-037Dietary supplement
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-041Dietary supplement
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-3Dietary supplement
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

Study groups in NCT02376608
Study group	Role	What they receive
Pronova Pure 150:500 EE EU	Active comparator	2 × PronovaPure 150:500 EE EU Receives: Dietary Supplement: Pronova Pure 150:500 EE EU; Dietary Supplement: Pronovum PRF-037; Dietary Supplement: Pronovum PRF-041; Dietary Supplement: Eskimo-3
Pronovum PRF-037	Active comparator	2 × Pronovum PRF-037 Receives: Dietary Supplement: Pronova Pure 150:500 EE EU; Dietary Supplement: Pronovum PRF-037; Dietary Supplement: Pronovum PRF-041; Dietary Supplement: Eskimo-3
Pronovum PRF-041	Active comparator	2 × Pronovum PRF-041 Receives: Dietary Supplement: Pronova Pure 150:500 EE EU; Dietary Supplement: Pronovum PRF-037; Dietary Supplement: Pronovum PRF-041; Dietary Supplement: Eskimo-3
Eskimo-3	Active comparator	3 × Eskimo-3 Receives: Dietary Supplement: Pronova Pure 150:500 EE EU; Dietary Supplement: Pronovum PRF-037; Dietary Supplement: Pronovum PRF-041; Dietary Supplement: Eskimo-3

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Sep 2014

First posted3 Mar 2015 (estimated)
Study startAug 2014
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Biological AvailabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02376608
Sponsor's protocol ID: CTN00714101
Status last verified: Aug 2014
First submitted: 10 Feb 2015
Last updated: 3 Mar 2015
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02376608
Acronym / sponsor ID: CTN00714101
Conditions: Biological Availability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Pronova BioPharmaIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 3 Mar 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Pronova Pure 150:500 EE EU	Active comparator	Dietary Supplement: Pronova Pure 150:500 EE EU, Dietary Supplement: Pronovum PRF-037, Dietary Supplement: Pronovum PRF-041, Dietary Supplement: Eskimo-32 × PronovaPure 150:500 EE EU
Pronovum PRF-037	Active comparator	Dietary Supplement: Pronova Pure 150:500 EE EU, Dietary Supplement: Pronovum PRF-037, Dietary Supplement: Pronovum PRF-041, Dietary Supplement: Eskimo-32 × Pronovum PRF-037
Pronovum PRF-041	Active comparator	Dietary Supplement: Pronova Pure 150:500 EE EU, Dietary Supplement: Pronovum PRF-037, Dietary Supplement: Pronovum PRF-041, Dietary Supplement: Eskimo-32 × Pronovum PRF-041
Eskimo-3	Active comparator	Dietary Supplement: Pronova Pure 150:500 EE EU, Dietary Supplement: Pronovum PRF-037, Dietary Supplement: Pronovum PRF-041, Dietary Supplement: Eskimo-33 × Eskimo-3

Who may qualify

Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pronova Pure 150:500 EE EUEach 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, Pronova Pure 150:500 EE EU, Pronovum PRF-037, Pronovum PRF-041
Pronovum PRF-037Each 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, Pronova Pure 150:500 EE EU, Pronovum PRF-037, Pronovum PRF-041
Pronovum PRF-041Each 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, Pronova Pure 150:500 EE EU, Pronovum PRF-037, Pronovum PRF-041
Eskimo-3Each 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, Pronova Pure 150:500 EE EU, Pronovum PRF-037, Pronovum PRF-041

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adam Strong, MD principal investigator

Covance Clinical Research Unit (CRU) Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pronova Pure 150:500 EE EU, Pronovum PRF-037 and Pronovum PRF-041 in people with Biological Availability, run by Pronova BioPharma at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under curve of omega-3 food supplements under light fed conditions in healthy subjects. (time frame: Pharmacikinetics up to 36 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02376608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.