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

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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00913250 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Bio-equivalence Study
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

Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00913250
C-869
No
Biogen Idec MD, Biogen Idec
Biogen Idec
Not Provided
Principal Investigator: Biogen-Idec Investigator Biogen Idec
Biogen Idec
June 2009

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