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

Phase 1CompletedNCT00913250

Biogen96 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Serum containing AvonexDRUG

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

Serum Free AvonexDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers.

Time frame: Study duration is 72 days

Data from ClinicalTrials.gov

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