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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2003-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Sequence 1

Serum containing Avonex followed by serum free Avonex

Group Type EXPERIMENTAL

Serum containing Avonex

Intervention Type DRUG

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

Sequence 2

Serum free Avonex followed by serum containing Avonex

Group Type EXPERIMENTAL

Serum Free Avonex

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Avonex Avonex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes