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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00913250
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Drug: Serum containing Avonex
Drug: Serum Free Avonex
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers. [ Time Frame: Study duration is 72 days ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: August 2003
Study Completion Date: October 2003
Arms Assigned Interventions
Experimental: Sequence 1
Serum containing Avonex followed by serum free Avonex
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
Other Name: Avonex
Experimental: Sequence 2
Serum free Avonex followed by serum containing Avonex
Drug: 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.
Other Name: Avonex

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913250

Sponsors and Collaborators
Biogen Idec
Investigators
Principal Investigator: Biogen-Idec Investigator Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00913250     History of Changes
Other Study ID Numbers: C-869
Study First Received: June 2, 2009
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Biogen Idec:
Multiple Sclerosis
Interferon beta-1a

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 16, 2014