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

NCT00913250 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2009-06-04

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Biogen-Idec Investigator · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-08-31
Completion
2003-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00913250 on ClinicalTrials.gov