Bioavailability of PRF-021 Compared to Omacor

• Research type

  Research Study

• Full title

  An Open Label, Randomised, Single-Dose Study to Evaluate the Bioavailability of PRF-021 Compared to Omacor in the Fed and Fasted State in Healthy Male and Female Subjects

• IRAS ID

  134467

• Sponsor organisation

  Pronova BioPharma Norge AS

• Eudract number

  2013-002375-18

• ISRCTN Number

  n/a

• Research summary

  PRF-021 is an omega-3 fatty acid for the treatment of high blood levels of triglycerides (fats) and also following a heart attack, to help prevent another one.

  Omacor is also an omega-3 fatty acids formulation which was developed by Pronova and is approved in several European countries. Omacor has been well tolerated in patients included in all clinical studies to date but the size of the capsule and fish taste experienced by some patients upon burping is considered to be a disadvantage. The purpose of this study is to determine if PRF-021 is more easily absorbed than Omacor therefore reaching similar effective levels in the blood stream but with a smaller dose.

  This is a single-site, open label, randomised sequence, 4-treatment, 4-period, single oral dose comparative study. Each subject will participate in 4 treatment periods and will receive a single dose of either 2000mg PRF-021 or 4000mg Omacor on Day 1 of each period. In total during the study each subject will receive two doses of PRF-021, one in a fasted state and the other in a fed state and two doses of Omacor, one in a fasted state and the other in a fed state. The order of treatments will be in accordance with a randomisation schedule

  The 4 treatment periods are separated by a minimum of 6 days. During each treatment period, subjects will reside at the CRU from Day –1 (the day before dosing) to Day 3.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  13/SC/0344

• Date of REC Opinion

  16 Jul 2013

• REC opinion

  Favourable Opinion