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Acasti Pharma Inc Completes PK Investigational New Drug Submission

Monday, 11 Nov 2013 08:30am EST 

Acasti Pharma Inc announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Pharmacokinetic (PK) trial of CaPre in the USA. 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 USA. 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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2 Jul 2015