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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:July 2012
End Date:September 2012
Contact:Medical Director
Email:neurologyclinicaltrials@biogenidec.com

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A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.


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.


This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of
BG-00012 given in capsule form supplied by two different manufactures.

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.
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