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

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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00913250

Enrollment

Registered

2009-06-04

Start date

2003-08-31

Completion date

2003-10-31

Last updated

2009-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Interferon beta-1a

Brief summary

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

Interventions

DRUGSerum containing Avonex

60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15

DRUGSerum Free Avonex

60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026