A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers - Full Text View

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00913250

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 I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Uncontrolled, Crossover Assignment, Bio-equivalence Study
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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Interferon beta 1a Interferons

U.S. FDA Resources

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
Sequence 1: Experimental 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
Sequence 2: Experimental 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.

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

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 ( Biogen Idec MD )
Study ID Numbers:	C-869
Study First Received:	June 2, 2009
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00913250 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biogen Idec:

Multiple Sclerosis
Interferon beta-1a

Additional relevant MeSH terms:

Anti-Infective Agents
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Interferon-beta

Sclerosis
Antiviral Agents
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on February 08, 2010