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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

NCT02359045 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2017-05-01

Study results available
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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.

Conditions

  • Relative Bioavailability
  • AUC
  • Cmax
  • Pharmacokinetics

Interventions

DRUG

D1400147

Treatment A

DRUG

D14000136

Treatment B

DRUG

D14000137

Treatment C

DRUG

Epanova®

Treatment D

Sponsors & Collaborators

Principal Investigators

  • Ronald Goldwater, Dr. · PAREXEL Early Phase Clinical Unit Baltimore, 3001 S. Hanover St., Baltimore, MD 21225, United States of America

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-12
Primary Completion
2015-07-27
Completion
2015-07-27

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02359045 on ClinicalTrials.gov