Trials / Completed
CompletedNCT00913250
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Serum containing Avonex | 60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15 |
| DRUG | Serum Free Avonex | 60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15. |
Timeline
- Start date
- 2003-08-01
- Completion
- 2003-10-01
- First posted
- 2009-06-04
- Last updated
- 2009-06-04
Source: ClinicalTrials.gov record NCT00913250. Inclusion in this directory is not an endorsement.