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

Relapsing Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center to assess the bioequivalence of Bafiertam (Monomethyl Fumarate) 190 mg (administered as 2 x 95 mg) Delayed-Release Capsules and Vumerity® (Diroximel Fumarate) 462 mg (Administered as 2 x 231 mg) Delayed-Release Capsules as assessed by plasma monomethyl fumarate concentrations in 40 healthy, non-smoking, male, and non-pregnant female volunteers under fasting conditions. ;

Study Design

Related Conditions & MeSH terms

  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting
  • Relapsing Remitting Multiple Sclerosis
Clinical Trial Details
NCT number NCT05181215
Study type Interventional
Source Banner Life Sciences LLC
Contact
Status Completed
Phase Phase 1
Start date May 14, 2021
Completion date August 27, 2021
View Details
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