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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT05181215

Public ClinicalTrials.gov record NCT05181215. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 29, 2026, 9:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Single-Dose, Randomized, Open-Label, Two-Way Crossover, Bioequivalence Study of Bafiertam (Monomethyl Fumarate) 190 mg and Vumerity® (Diroximel Fumarate) 462 mg Delayed-Release Capsules in Fasting Healthy Male and Female Subjects

Study identification

NCT ID
NCT05181215
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Banner Life Sciences LLC
Industry
Enrollment
46 participants

Conditions and interventions

Interventions

  • Diroximel Fumarate 462 mg Drug
  • Monomethyl Fumarate 190 Mg Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 13, 2021
Primary completion
Aug 26, 2021
Completion
Aug 26, 2021
Last update posted
Jan 5, 2022

2021

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
BioPharma Services, Inc. St Louis Missouri 63141

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05181215, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 5, 2022 · Synced Apr 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05181215 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →