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
-
This study is a randomized, open-label, cross-over study in healthy subjects performed at a single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of the study is to compare the pharmacokinetics (PK) of three different prototype capsule formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be used as basis for choice of formulation for further pharmaceutical development.
To assess the relative bioavailability of the different omega-3-carboxylic acids prototype capsule formulations in relation to Epanova® capsules 1000 mg under fed and fasted conditions.
Location
Location
Baltimore, MD, United States
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 |
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