Pharmacokinetics Clinical Trial
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
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. ;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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