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Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Serum containing Avonex followed by serum free Avonex |
|
| Sequence 2 | Experimental | Serum free Avonex followed by serum containing Avonex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum containing Avonex | Drug | 60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15 |
|
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria apply as per protocol
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| Name | Affiliation | Role |
|---|---|---|
| Biogen-Idec Investigator | Biogen | Principal Investigator |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| Serum Free Avonex | Drug | 60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15. |
|
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |