A Bioequivalence Study of Serum Free Avonex and Serum Containing Avone
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
What it found
We found no results in the registry or in papers.
This trial finished 23 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers.
Study duration is 72 days
Who could take part
MS (type not specified) · 18 to 45
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.
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History
Started
Aug 2003
Finished
Oct 2003