Pharmacokinetics of interferon alpha-2b in healthy volunteers.
In a three-way crossover design, 12 healthy male volunteers received 5 X 10(6) IU/m2 body surface area interferon alpha-2b(IFN alpha-2b) by intravenous (IV) infusion over 30 minutes, intramuscular (IM) injections, and subcutaneous (SC) injections. Blood and urine samples were collected at specified times, and analysis of IFN alpha-2b concentrations was performed by immunoradiometric assay. "Flulike" symptoms were the most frequently reported adverse experiences and were independent of the route of administration. After a 30-minute IV infusion, IFN alpha-2b disappeared rapidly from serum, with distribution and elimination phase half-lives of 0.1 hour and 1.7 hours, respectively. Interferon alpha-2b was absorbed slowly after IM and SC administration, with similar absorption half-lives of 5.8 and 5.5 hours, respectively. The observed maximal concentrations after IM and SC administration were 42.1 IU/mL at six hours and 45.8 IU/mL at eight hours, respectively. Interferon alpha-2b was eliminated with half-lives of 2.2 hours after IM administration and 2.9 hours after SC administration. The areas under the serum concentration-time curves for the SC and IM doses were higher than those obtained for the IV infusion. Measurable amounts of IFN alpha-2b were not found in urine regardless of the route of administration.
Department of Drug Metabolism and Pharmacokinetics, Schering Corporation, Bloomfield, New Jersey 07003.
E
E
Radwanski
G
G
Perentesis
S
S
Jacobs
E
E
Oden
M
M
Affrime
S
S
Symchowicz
N
N
Zampaglione
D000328:Adult; D001682:Biological Availability; D006207:Half-Life; D006801:Humans; D007262:Infusions, Intravenous; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D007370:Interferon Type I / Q000493:pharmacokinetics*; D008297:Male
D007370:Interferon Type I