title: Influence of human serum albumin content in formulations on the bioequivalency of interferon alfa-2a given by subcutaneous injection in healthy male volunteers.
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.
authors.affiliation: Hoffmann-La Roche, Inc., Nutley, NJ 07110-1199, USA.
authors.forename: J
authors.initials: J
authors.lastname: Zhi
authors.forename: S B
authors.initials: SB
authors.lastname: Teller
authors.forename: H
authors.initials: H
authors.lastname: Satoh
authors.forename: S G
authors.initials: SG
authors.lastname: Koss-Twardy
authors.forename: D R
authors.initials: DR
authors.lastname: Luke
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004361:Drug Tolerance; D005079:Excipients; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D008297:Male; D011994:Recombinant Proteins; D012709:Serum Albumin / Q000378:metabolism*; D013810:Therapeutic Equivalency
chemical_list: D005079:Excipients; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012709:Serum Albumin