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

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

June 2, 2009
June 3, 2009
August 2003
Not Provided
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 ]
Same as current
No Changes Posted
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A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers
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
Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Multiple Sclerosis
  • 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
  • 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
  • Experimental: Sequence 1
    Serum containing Avonex followed by serum free Avonex
    Intervention: Drug: Serum containing Avonex
  • Experimental: Sequence 2
    Serum free Avonex followed by serum containing Avonex
    Intervention: Drug: Serum Free Avonex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
October 2003
Not Provided

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

Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00913250
C-869
No
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Biogen Idec MD, Biogen Idec
Biogen
Not Provided
Principal Investigator: Biogen-Idec Investigator Biogen
Biogen
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP