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FDA clears Acasti Pharma Inc's investigational new drug submission to conduct pk trial

Thursday, 9 Jan 2014 07:30am EST 

Acasti Pharma Inc:Says U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) submission to initiate a Pharmacokinetic (PK) trial of CaPre in the U.S., having found no objections with the PK trial design, protocol, or safety profile of CaPre.Says PK trial is an open-label, randomized, multiple-dose, single-center, parallel-design study that will evaluate blood profiles and bioavailability of omega-3 phospholipids on 42 healthy volunteers taking single and multiple daily oral doses of 1, 2 and 4 grams of CaPre. 

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-0.03 -2.88%
17 Sep 2014