NCT02171208

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	dimethyl fumarate - Reference form	single dose 240 mg
DRUG	dimethyl fumarate - Test form	single dose 240 mg

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-06-24
• Last updated: 2015-01-09

Locations

2 sites across 1 country: United States