The aim of this study is to demonstrate the bioequivalence of DOXIL/CAELYX, 40 mg/m2 (IV
infusion over 90 minutes) between two manufacturing facilities. According to the Food and
Drug Administration (FDA), two products are considered to be bioequivalent when they are
equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes
available at the site(s) of drug action. Any abnormalities of the safety endpoints (Clinical
Laboratory Test, Electrocardiogram, Left Ventricular Ejection Fraction, Physical Examination)
will be captured as Adverse Events.