NCT02376621

Brief Summary

The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted conditions in healthy adult subjects. Each subject will participate in 5 treatment periods. The order of treatments will be in accordance with the randomisation schedule.There will be a minimum of 4 treatment-free days between each treatment period. On each dosing occasion, subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing. Twenty-four subjects will be enrolled to complete dosing of 20 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 healthy

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1 healthy

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

October 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
Last Updated

March 3, 2015

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

February 11, 2015

Last Update Submit

February 25, 2015

Conditions

Healthy

Keywords

omega-3 based dietary supplementsBioavailability

Outcome Measures

Primary Outcomes (2)

  • Area under curve of omega-3 based dietary supplements under fasted conditions.

    Pharmacokinetics up to 36 hours postdose

  • Peak plasma concentration of omega-3 based dietary supplements under fasted conditions.

    Pharmacokinetics up to 36 hours postdose

Study Arms (5)

PronovaPure 150:500 triglycerides

ACTIVE COMPARATOR

3 × PronovaPure 150:500 triglycerides (TG) European Union (EU)

Dietary Supplement: PronovaPure 150:500 triglyceridesDietary Supplement: Pronovum PRF-048Dietary Supplement: Pronovum PRF-037Dietary Supplement: PronovaPure 500:200 TGDietary Supplement: Pronovum PRF-047

Pronovum PRF-048

ACTIVE COMPARATOR

3 × Pronovum PRF-048

Dietary Supplement: PronovaPure 150:500 triglyceridesDietary Supplement: Pronovum PRF-048Dietary Supplement: Pronovum PRF-037Dietary Supplement: PronovaPure 500:200 TGDietary Supplement: Pronovum PRF-047

Pronovum PRF-037

ACTIVE COMPARATOR

3 × Pronovum PRF-037

Dietary Supplement: PronovaPure 150:500 triglyceridesDietary Supplement: Pronovum PRF-048Dietary Supplement: Pronovum PRF-037Dietary Supplement: PronovaPure 500:200 TGDietary Supplement: Pronovum PRF-047

PronovaPure 500:200 TG

ACTIVE COMPARATOR

3 × PronovaPure 500:200 TG EU

Dietary Supplement: PronovaPure 150:500 triglyceridesDietary Supplement: Pronovum PRF-048Dietary Supplement: Pronovum PRF-037Dietary Supplement: PronovaPure 500:200 TGDietary Supplement: Pronovum PRF-047

Pronovum PRF-047

ACTIVE COMPARATOR

3 × Pronovum PRF-047

Dietary Supplement: PronovaPure 150:500 triglyceridesDietary Supplement: Pronovum PRF-048Dietary Supplement: Pronovum PRF-037Dietary Supplement: PronovaPure 500:200 TGDietary Supplement: Pronovum PRF-047

Interventions

PronovaPure 150:500 triglyceridesDIETARY_SUPPLEMENT

Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

PronovaPure 150:500 triglyceridesPronovaPure 500:200 TGPronovum PRF-037Pronovum PRF-047Pronovum PRF-048
Pronovum PRF-048DIETARY_SUPPLEMENT

Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

PronovaPure 150:500 triglyceridesPronovaPure 500:200 TGPronovum PRF-037Pronovum PRF-047Pronovum PRF-048
Pronovum PRF-037DIETARY_SUPPLEMENT

Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

PronovaPure 150:500 triglyceridesPronovaPure 500:200 TGPronovum PRF-037Pronovum PRF-047Pronovum PRF-048
PronovaPure 500:200 TGDIETARY_SUPPLEMENT

Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

PronovaPure 150:500 triglyceridesPronovaPure 500:200 TGPronovum PRF-037Pronovum PRF-047Pronovum PRF-048
Pronovum PRF-047DIETARY_SUPPLEMENT

Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

PronovaPure 150:500 triglyceridesPronovaPure 500:200 TGPronovum PRF-037Pronovum PRF-047Pronovum PRF-048

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males or females
  • any ethnic origin
  • age 40 - 65 years
  • 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 taken within 14 days
  • taken supplements containing omega-3 faty acids or fish oil last 14 days or any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days
  • taken any medication including St. John's Worth known to alter drug absorption within 30 days
  • subjects participating in a clinical study past 3 months
  • recent blood donation
  • significant history of drug allergy or any allergic disease
  • allergy or hypersensitivity to omega-3 fatty acids, fish, soya, oleic acid, sesame oil or other constituents of pharmaceutical preparation.
  • high consumption of tobacco
  • high consumption of alcohol
  • other significant medical history or physical findings (including HIV,hepatitis)
  • vegetarians
  • not willing to follow dietary restrictions
  • frequent migraine attacks
  • previously taken part in or withdrawn from study or according to investigator should not participate.

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

MeSH Terms

Interventions

Triglycerides

Intervention Hierarchy (Ancestors)

GlyceridesLipids

Study Officials

  • Ashley Brooks, MD

    Covance Clinical Research Unit (CRU) Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 11, 2015

First Posted

March 3, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 3, 2015

Record last verified: 2015-02

Locations

GB(1)