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

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Serum containing Avonex (Drug); Serum Free Avonex (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Biogen-Idec Investigator, Principal Investigator, Affiliation: Biogen

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

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

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: August 2003
Last updated: June 3, 2009

Page last updated: August 23, 2015

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