A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers

Completed · Phase 1

Conditions studied: Healthy

In brief

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).

Key facts

Study ID
NCT02171208
Run by
Biogen
People needed
80
Starts
2014-06-01
Expected to finish
2014-07-01
Last updated by the study team
2015-01-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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