Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-26 @ 1:37 PM
Study NCT ID:
NCT00913250
Status:
COMPLETED
Last Update Posted:
2009-06-04
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers
Sponsor:
Biogen
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: