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

NCT04570670 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-12-30

Study results available
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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.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

monomethyl fumarate 190 mg

DRUG

dimethyl fumarate 240 mg

Sponsors & Collaborators

  • Banner Life Sciences LLC

    lead INDUSTRY

Principal Investigators

  • Franck Rousseau, MD · Banner Life Sciences LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-06
Primary Completion
2017-02-17
Completion
2017-02-17
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04570670 on ClinicalTrials.gov