A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biogen
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Healthy Volunteers

Exclusion Criteria:

• History of severe allergic or anaphylactic reactions

• History of hypersensitivity to acetaminophen (paracetamol), ibuprofen, or codeine.

• Known allergy to dry natural rubber

• History of seizure disorder or unexplained blackouts

• History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease

Other inclusion and exclusion criteria apply as per protocol