drugset
drugset / Trial / NCT04022473

Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers

NCT04022473 ↗

Phase 1 Completed 210 enrolled Banner Life Sciences LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate). Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfidera® when administered orally following bioequivalent dose regimens in healthy subjects.

Timeline

Start
2019-07-07
Primary completion
2019-10-19
Completion
2019-10-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator dimethyl fumarate Unknown 240 mg Oral
Subject monomethyl fumarate Small molecule 190 mg Oral

Indications

multiple sclerosis