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

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Serum Free Avonex; Drug: Serum containing Avonex

• Registration Number: NCT00913250
• Lead Sponsor: Biogen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study Completion: 2003-10
• Status Verified: 2009-06
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Last Update Submitted: 2009-06-03
• Study First Posted: 2009-06-04
• Last Update Posted: 2009-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	Serum Free Avonex	Serum free Avonex followed by serum containing Avonex
Sequence 1	Serum containing Avonex	Serum containing Avonex followed by serum free Avonex

Primary Outcome Measures

Name	Time	Method
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