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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biogen
• Treatments: Dimethyl Fumarate

Criteria

Inclusion Criteria:

• Must give written and informed consent and any authorizations required by local law.

• Males and females 18 - 55 years old inclusive at time of consent.

• Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

• History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).

• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator.

• Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).

• Current enrollment in any other drug, biologic, or device study.