NCT02359045

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Relative Bioavailability
• AUC
• Cmax
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	D1400147	Treatment A
DRUG	D14000136	Treatment B
DRUG	D14000137	Treatment C
DRUG	Epanova®	Treatment D

Timeline

• Start date: 2015-02-12
• Primary completion: 2015-07-27
• Completion: 2015-07-27
• First posted: 2015-02-09
• Last updated: 2017-05-01
• Results posted: 2017-05-01

Locations

1 site across 1 country: United States