NCT00913250: Two Avonex manufacturing formulations compared

Medicine Signal Editorial Desk
Updated 2026-10-10

Registry status when checked 2026-10-10Completed

Study: Bioequivalence of serum-free and serum-containing manufacturing formulations of Avonex/interferon beta-1a, sponsored by Biogen. 1 2

Design and measurements: This phase I randomized, single-blind crossover study records 96 actual healthy adult participants, aged 18–45. The protocol administered 60-microgram intramuscular doses of the two formulations on separate study days and compared pharmacokinetic exposure. These are experimental protocol details, not routine multiple-sclerosis dosing instructions. 1 2

What is established: The record gives study completion in October 2003 and first registration in June 2009. Numerical exposure ratios and confidence intervals were not verified. “Serum-free” refers to formulation/manufacturing, not the absence of serum in a participant. This study does not measure relapse or disability outcomes in patients with multiple sclerosis. 1 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00913250. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00913250. Original study registration: sponsor, design, population, endpoints and dated history.

2. ICH GCP — ICH GCP — readable reproduction of the sponsor-submitted ClinicalTrials.gov record. Supports the registration details quoted here; not an independent clinical-results publication.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.