Pharmacokinetics and Bioavailability of Monomethyl Fumarate Following a Single Oral Dose of Bafiertam™ (Monomethyl Fumarate) or Tecfidera^® (Dimethyl Fumarate).

ABSTRACT:

Background

Tecfidera^® (dimethyl fumarate [DMF]) is an approved product for the treatment of relapsing forms of multiple sclerosis. Monomethyl fumarate (MMF) is the only active metabolite of DMF and is responsible for its therapeutic efficacy.

Objective

The objective of this study was to determine whether two Bafiertam™ capsules each containing 95 mg of MMF is bioequivalent to one Tecfidera^® capsule containing 240 mg of DMF, a prodrug of MMF.

Methods

This was a single-dose, open-label, randomized, two-way crossover study evaluating two treatments over two periods with a washout interval between treatments. Fifty healthy subjects were randomized to receive a single dose of the test drug MMF 190 mg as 2 × 95 mg delayed-release capsules or the refere

SUBMITTER: Lategan TW 

PROVIDER: S-EPMC8144082 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature