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Amarin Corporation PLC Announces Positive Results Of Phase 1 Clinical Trial


Friday, 21 Jun 2013 06:00am EDT 

Amarin Corporation plc announced that the results from a Phase One clinical trial that compared bioavailability of components from a fixed-dose combination of its flagship product, Vascepa (icosapent ethyl), plus rosuvastatin, to concomitant administration of the two agents independently, and to rosuvastatin alone. In the multiple-dose study of 48 healthy volunteers, AMR-102 (the fixed-dose combination of icosapent ethyl and rosuvastatin, a leading statin) was assessed versus simultaneous administration of the individual agents, as well as versus rosuvastatin monotherapy, on pharmacokinetic measurements in order to show feasibility of the fixed-dose combination. The results proved promising, as there was no inhibition of either the rosuvastatin bioavailability, or of the bioavailability of the active metabolite EPA from Vascepa, observed with the fixed-dose combination product compared to the other arms of the trial. 

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