A Randomized, Double-Blind, Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers (Vifor SA and Biogen Idec OSD)

NCT02171208 Phase 1 COMPLETED

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).

Details

Lead sponsor	Biogen
Phase	Phase 1
Status	COMPLETED
Enrolment	80
Start date	2014-06
Completion	2014-07

Conditions

• Healthy

Interventions

• dimethyl fumarate - Reference form
• dimethyl fumarate - Test form

Primary outcomes

• Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012 — Up to 48 hours following each dose administration
• Maximum observed concentration (Cmax) of BG00012 — Up to 48 hours following each dose administration

Countries

United States