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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Banner Life Sciences LLC
Study ID
NCT05181215
Phase
PHASE1
Status
Completed

Conditions

  • Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Monomethyl Fumarate 190 Mg — DRUG
    2 x oral 95 mg capsules, delayed-release
  • Diroximel Fumarate 462 mg — DRUG
    2 x 231 mg capsules, delayed-release

Study Details

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

Key Dates

Start date
May 14, 2021
Status verified
Dec 2021
Primary completion
Aug 27, 2021
Completion
Aug 27, 2021

Study Design

Enrollment
46 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Bafiertam
    190 mg (2 x 95 mg) delayed-release capsules
  • Active Comparator: Vumerity
    462 mg (2 x 231 mg) delayed-release capsules

Primary Outcome Measure

The Bioequivalent (BE) Comparison of AUC0-inf of Monomethyl Fumarate (MMF) Between Treatments [ Time Frame: 24 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
BioPharma Services, Inc.St LouisMissouri63141-

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