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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913250
First Posted: June 4, 2009
Last Update Posted: June 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biogen
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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:

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913250


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

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00913250     History of Changes
Other Study ID Numbers: C-869
First Submitted: June 2, 2009
First Posted: June 4, 2009
Last Update Posted: June 4, 2009
Last Verified: June 2009

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

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