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.
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- earlier participated in or withdrawn from the study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
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.
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Pronova BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Strong, MD, Principal investigator, Covance Clinical Research Unit (CRU) Ltd.
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.
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 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.
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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?
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.