NCT02376608

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
Last Updated

March 3, 2015

Status Verified

August 1, 2014

Enrollment Period

1 month

First QC Date

February 10, 2015

Last Update Submit

February 25, 2015

Conditions

Biological Availability

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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.

Study Arms (4)

Pronova Pure 150:500 EE EU

ACTIVE COMPARATOR

2 × PronovaPure 150:500 EE EU

Dietary Supplement: Pronova Pure 150:500 EE EUDietary Supplement: Pronovum PRF-037Dietary Supplement: Pronovum PRF-041Dietary Supplement: Eskimo-3

Pronovum PRF-037

ACTIVE COMPARATOR

2 × Pronovum PRF-037

Dietary Supplement: Pronova Pure 150:500 EE EUDietary Supplement: Pronovum PRF-037Dietary Supplement: Pronovum PRF-041Dietary Supplement: Eskimo-3

Pronovum PRF-041

ACTIVE COMPARATOR

2 × Pronovum PRF-041

Dietary Supplement: Pronova Pure 150:500 EE EUDietary Supplement: Pronovum PRF-037Dietary Supplement: Pronovum PRF-041Dietary Supplement: Eskimo-3

Eskimo-3

ACTIVE COMPARATOR

3 × Eskimo-3

Dietary Supplement: Pronova Pure 150:500 EE EUDietary Supplement: Pronovum PRF-037Dietary Supplement: Pronovum PRF-041Dietary Supplement: Eskimo-3

Interventions

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

Eskimo-3Pronova Pure 150:500 EE EUPronovum PRF-037Pronovum PRF-041
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

Eskimo-3Pronova Pure 150:500 EE EUPronovum PRF-037Pronovum PRF-041
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-3Pronova Pure 150:500 EE EUPronovum PRF-037Pronovum PRF-041
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

Eskimo-3Pronova Pure 150:500 EE EUPronovum PRF-037Pronovum PRF-041

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street

Leeds, LS2 9LH, United Kingdom

Location

Study Officials

  • Adam Strong, MD

    Covance Clinical Research Unit (CRU) Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

March 3, 2015

Study Start

August 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 3, 2015

Record last verified: 2014-08

Locations

GB(1)