Amarin Corporation plc AMRN, a biopharmaceutical company focused on
the commercialization and development of therapeutics to improve
cardiovascular health, announced today that it has completed dosing and
pharmacokinetic sampling in a study to test a fixed-dose combination of
Vascepa^® (icosapent ethyl) capsules and a leading statin. The clinical name
for this combination product is AMR102. Prior to commencement of the study,
Amarin opened an Investigational New Drug Application (IND) with the U.S. Food
and Drug Administration which became effective after the standard 30-day
review.
The purpose of this AMR102 study is to determine the bioavailability of the
EPA (eicosapentaenoic acid) and statin components when taken as a fixed-dose
combination product, relative to the individual reference agents taken
concomitantly. Statin bioavailability from both the fixed-dose and concomitant
regimens will also be compared with that from the reference statin taken alone
in healthy subjects. Additionally, pharmacokinetic data from this study will
be examined to explore relationships between in vitro dissolution data and in
vivo pharmacokinetic data. The study is designed as a randomized, open-label,
multiple dose, parallel-group study in 48 healthy subjects conducted at a
single site in the United States.
Amarin looks forward to analyzing the results from this study and expects to
communicate such results in the first half of 2013.
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