INFLUENCE OF HUMAN SERUM-ALBUMIN CONTENT IN FORMULATIONS ON THE BIOEQUIVALENCY OF INTERFERON ALFA-2A GIVEN BY SUBCUTANEOUS INJECTION IN HEALTHY MALE-VOLUNTEERS

To determine the influence of human serum albumin (HSA) content in for mulations on the bioequivalency of recombinant interferon alfa-2a, a d ouble-blind, randomized, two-way crossover study was conducted in 24 h ealthy male volunteers. Subjects received a single subcutaneous inject ion of 18 million IU of Roferon-A reconstituted with either the diluen t containing 10 mg of HSA or the HSA-free diluent; final HSA contents in the 2 formulations were 15 mg and 5 mg, respectively. Administratio n of the 2 formulations resulted in similar 48-hour Roferon-A serum co ncentration-time profiles and comparable frequency and intensity of ad verse events. The statistical analysis using the two one-sided tests p rocedure showed that both formulations were bioequivalent for pharmaco kinetic parameters such as C-max, t(max), AUC(48), and AUC. We conclud e that a threefold change in HSA content in formulations does not alte r the bioequivalency of Roferon-A.