Study identifier:D5884C00003
ClinicalTrials.gov identifier:NCT02359045
EudraCT identifier:N/A
CTIS identifier:N/A
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
Relative bioavailability,, AUC,
Phase 1
Yes
D1400147, D14000136, D14000137, Epanova®
Male
137
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Bio-availability
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Mar 2017 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part 1: Treatment A-B-C-D Subjects received a single dose of D1400147 (Treatment A: Omega-3-carboxylic acids 2000 mg uncoated capsules), D14000136 (Treatment B: Omega-3-carboxylic acids 2000 mg coated capsules coat 1), D14000137 (Treatment C: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) and Epanova® (Treatment D: Epanova capsules 1000 mg) under fasted condition. | Drug: D1400147 Treatment A Drug: D14000136 Treatment B Drug: D14000137 Treatment C Drug: Epanova® Treatment D |
Experimental: Part 2: Treatment A-B/C-D Subjects received a single dose of D1400147 (Treatment A: Omega-3-carboxylic acids 2000 mg uncoated capsules), D14000136 (Treatment B: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) or D14000137 (Treatment C: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) and Epanova® (Treatment D: Epanova capsules 1000 mg) under fed condition. | Drug: D1400147 Treatment A Drug: D14000136 Treatment B Drug: D14000137 Treatment C Drug: Epanova® Treatment D |