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Trials & Filings

Acasti Files IND

To conduct PK study of CaPre

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Acasti Pharma, a subsidiary of Neptune Technologies & Bioresources Inc., has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Pharmacokinetic trial 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.

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