Status:
COMPLETED
Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012
Lead Sponsor:
Biogen
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.
Detailed Description
This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..
Eligibility Criteria
Inclusion
- 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
- History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- Known history of or positive test result for Human Immunodeficiency Virus (HIV)
- History of severe allergic or anaphylactic reactions.
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01420458
Start Date
August 1 2011
End Date
September 1 2011
Last Update
November 4 2011
Active Locations (1)
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1
Research Site
Minneapolis, Minnesota, United States