Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects

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.

Timeline

Start

2017-01-06

Primary completion

2017-02-17

Completion

2017-02-17

Outcome

Met primary endpoint

paper CONCLUSIONS: Based on the statistical analysis results of the pharmacokinetic parameters of MMF, a single oral dose of two Bafiertam™ DR 95 mg capsules is bioequivalent to a single oral dose of one Tecfidera® DR 240 mg capsule. PMID 33797063 ↗

Publications

• Results Lategan TW, Wang L, Sprague TN, Rousseau FS. Pharmacokinetics and Bioavailability of Monomethyl Fumarate Following a Single Oral Dose of Bafiertam (Monomethyl Fumarate) or Tecfidera(R) (Dimethyl Fumarate). CNS Drugs. 2021 May;35(5):567-574. doi: 10.1007/s40263-021-00799-9. Epub 2021 Mar 30.

Drugs

Indications