NCT05181215

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Banner Life Sciences LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-14
• Primary completion: 2021-08-27
• Completion: 2021-08-27
• First posted: 2022-01-06
• Last updated: 2022-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study