Influence of Human Serum Albumin Content in Formulations on the Bioequivalency of Interferon Alfa‐2a Given by Subcutaneous Injection in Healthy Male Volunteers

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Abstract
To determine the influence of human serum albumin (HSA) content in formulations on the bioequivalency of recombinant interferon alfa‐2a, a double‐blind, randomized, two‐way crossover study was conducted in 24 healthy male volunteers. Subjects received a single subcutaneous injection of 18 million IU of Roferon‐A reconstituted with either the diluent containing 10 mg of HSA or the HSA‐free diluent; final HSA contents in the 2 formulations were 15 mg and 5 mg, respectively. Administration of the 2 formulations resulted in similar 48‐hour Roferon‐A serum concentration‐time profiles and comparable frequency and intensity of adverse events. The statistical analysis using the two one‐sided tests procedure showed that both formulations were bioequivalent for pharmacokinetic parameters such as Cmax, tmax, AUC48, and AUC. We conclude that a threefold change in HSA content in formulations does not alter the bioequivalency of Roferon‐A.