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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||A Randomized, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of Two Formulations of BG00012.|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..