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Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012

This study has been completed.
Information provided by:
Biogen Identifier:
First received: August 11, 2011
Last updated: November 3, 2011
Last verified: November 2011

August 11, 2011
November 3, 2011
August 2011
September 2011   (Final data collection date for primary outcome measure)
Area under the plasma concentration curve as a measure of PK. [ Time Frame: Participants will be followed during the duration of the study, 4 days. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs ]
Same as current
Complete list of historical versions of study NCT01420458 on Archive Site
The number of AEs in participants as a measure of safety and tolerability. [ Time Frame: Participants will be followed during the time of study - an estimated four days ]
Same as current
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Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012
A Randomized, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of Two Formulations of BG00012.
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.
This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteers
Drug: Experimental
Bioequivalence of two drug formulations
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2011
September 2011   (Final data collection date for primary outcome measure)

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).
  • 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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Medical Director, Biogen Idec
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Not Provided
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP