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Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.

NCT01632449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-05-31

No results posted yet for this study

Summary

This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Test product

Dimethyl Fumarate (BG00012)

DRUG

Reference product

Dimethyl Fumarate (BG00012)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01632449 on ClinicalTrials.gov