A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to establish the bioequivalence of the test product
(BG00012 [dimethyl fumarate] supplied by Biogen Idec OSD) to the reference product (BG00012
supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers.
The secondary objectives of this study are to determine the safety and tolerability of the
test product compared to the reference product, to estimate PK parameters of the test product
and the reference product, and to estimate the intra-subject coefficient of variation (CV%)
of the referenced product for both area under the plasma concentration curve (AUC) and peak
plasma concentration (Cmax).