Conditions: Relative Bioavailability AUC Cmax Pharmacokinetics
Keywords: Omega-3-carboxylic acids, Phase I, Healthy Subjects, Pharmacokinetics, Relative bioavailability
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 137
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: D1400147 intervention 2: D14000136 intervention 3: D14000137 intervention 4: Epanova®
Intervention descriptions: intervention 1: Treatment A intervention 2: Treatment B intervention 3: Treatment C intervention 4: Treatment D

Protocol document: