A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of AVONEX® (Interferon Beta-1a) Solutions for Injection Produced by a Serum-Containing Manufacturing Process and by a Serum-Free Manufacturing Process

NCT00913250 Phase 1 COMPLETED

Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.

Details

Lead sponsor	Biogen
Phase	Phase 1
Status	COMPLETED
Enrolment	96
Start date	2003-08
Completion	2003-10

Conditions

• Multiple Sclerosis

Interventions

• Serum containing Avonex
• Serum Free Avonex

Primary outcomes

• To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers. — Study duration is 72 days