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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014