Status:
COMPLETED
A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.
Eligibility Criteria
Inclusion
- Healthy Volunteers
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00913250
Start Date
August 1 2003
End Date
October 1 2003
Last Update
June 4 2009
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