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

Biogen

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: Serum Free Avonex; Drug: Serum containing Avonex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913250

C-869

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Sequence 1

Experimental group

Description:

Serum containing Avonex followed by serum free Avonex

Treatment:

Drug: Serum containing Avonex

Sequence 2

Experimental group

Description:

Serum free Avonex followed by serum containing Avonex

Treatment:

Drug: Serum Free Avonex