Study in healthy subjects to compare the concentrations of the omega-3 fatty acids EPA and DHA in blood when delivered as three new capsules in relation to the Epanova® capsule under fasting and fed conditions

Study identifier:D5884C00003

ClinicalTrials.gov identifier:NCT02359045

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomized, open-label, single-center, cross-over study in healthy subjects to assess the relative bioavailability of EPA and DHA delivered by three new capsule formulation prototypes in relation to the current Epanova® capsule under fasting (Part 1) and fed (Part 2) conditions

Medical condition

Relative bioavailability,, AUC,

Phase

Phase 1

Healthy volunteers

Yes

Study drug

D1400147, D14000136, D14000137, Epanova®

Sex

Male

Actual Enrollment

137

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 12 Feb 2015
Primary Completion Date: 27 Jul 2015
Study Completion Date: 27 Jul 2015

Study design

Allocation: Randomized
Endpoint Classification: Bio-availability
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Mar 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria