Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
Status:
Completed
Trial end date:
2017-02-17
Target enrollment:
Participant gender:
Summary
The primary objective of this study was to assess the bioequivalence of the test product
(Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg
based on the Cmax and Area Under the Curve (AUC) values of monomethyl fumarate (MMF)
determined after a single dose under fasting conditions.