11.11.13
Acasti Pharma, Laval, Québec, Canada, a subsidiary of Neptune Technologies & Bioressources Inc., has submitted an Investigational New Drug (IND) application to the U.S. FDA to initiate a Pharmacokinetic (PK) trial of CaPre in the U.S.
The proposed PK trial is the first step in the Corporation’s U.S. clinical strategy to initiate PK and Phase III trials of CaPre in the U.S. It is an open-label, randomized, multiple-dose, single-center, parallel-design study that will evaluate blood profiles and bioavailability of omega-3 phospholipids on healthy volunteers taking single and multiple daily oral doses of 1, 2 and 4 grams of CaPre.
The proposed PK trial is the first step in the Corporation’s U.S. clinical strategy to initiate PK and Phase III trials of CaPre in the U.S. It is an open-label, randomized, multiple-dose, single-center, parallel-design study that will evaluate blood profiles and bioavailability of omega-3 phospholipids on healthy volunteers taking single and multiple daily oral doses of 1, 2 and 4 grams of CaPre.