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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Serum containing Avonex
Serum Free Avonex
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Interferon beta-1a

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Sequence 1

    Sequence 2

    Arm Description

    Serum containing Avonex followed by serum free Avonex

    Serum free Avonex followed by serum containing Avonex

    Outcomes

    Primary Outcome Measures

    To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 2, 2009
    Last Updated
    June 3, 2009
    Sponsor
    Biogen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00913250
    Brief Title
    A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Biogen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Multiple Sclerosis, Interferon beta-1a

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sequence 1
    Arm Type
    Experimental
    Arm Description
    Serum containing Avonex followed by serum free Avonex
    Arm Title
    Sequence 2
    Arm Type
    Experimental
    Arm Description
    Serum free Avonex followed by serum containing Avonex
    Intervention Type
    Drug
    Intervention Name(s)
    Serum containing Avonex
    Other Intervention Name(s)
    Avonex
    Intervention Description
    60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15
    Intervention Type
    Drug
    Intervention Name(s)
    Serum Free Avonex
    Other Intervention Name(s)
    Avonex
    Intervention Description
    60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15.
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Biogen-Idec Investigator
    Organizational Affiliation
    Biogen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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