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Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects

NCT05181215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-01-06

No results posted yet for this study

Summary

A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center, bioequivalence study of Bafiertam and Vumerity.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

Monomethyl Fumarate 190 Mg

2 x oral 95 mg capsules, delayed-release

DRUG

Diroximel Fumarate 462 mg

2 x 231 mg capsules, delayed-release

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
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2021-08-27
Completion
2021-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05181215 on ClinicalTrials.gov