At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 50 enrolled
Drug / intervention
monomethyl fumarate 190 mg +1 moredrug
Likely dose
monomethyl fumarate 190 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating monomethyl fumarate 190 mg and dimethyl fumarate 240 mg for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 50 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Remitting Multiple Sclerosis
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJan 2017
Primary CompletionFeb 2017
First PostedSep 2020
TodayJul 2026
First PostedSep 30, 2020
Enrollment StartJan 6, 2017
Primary CompletionFeb 17, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 5.8 years ago
Interventions
monomethyl fumarate 190 mgdrug
dimethyl fumarate 240 mgdrug