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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913250
• Other study ID #: C-869
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2009
• Last updated: June 3, 2009
• Start date: August 2003
• Est. completion date: October 2003

Study information

• Verified date: June 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Serum containing Avonex
60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15
• Serum Free Avonex
60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No