Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05181215 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects
A Phase 1 study, sponsored by Banner Life Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT05181215: Completed Phase 1 study, sponsored by Banner Life Sciences.
NCT05181215 is a Phase 1 study that has completed, run by Banner Life Sciences. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05181215, a Phase 1 study, has completed, sponsored by Banner Life Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
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.
Primary Outcome
Pharmacokinetics: Plasma concentrations of MMF will be determined and used to calculate AUC0-inf MMF for each treatment. Venous blood samples were collected immediately prior to dosing (time 0), and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 14, 16, 18, 20, 22, and 24 hours postdose.
Interventions
- DRUG Monomethyl Fumarate 190 Mg
- DRUG Diroximel Fumarate 462 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-05-14 |
| Est. Completion | 2021-08-27 |
| Phase | Phase 1 |
What the finished NCT05181215 record still lists
NCT05181215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Monomethyl Fumarate 190 Mg is the first listed.
NCT05181215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05181215 about?
NCT05181215 is a clinical study titled "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, two-period, two-sequence, two-treatment, single-center, bioequivalence study of Bafiertam and Vumerity.
What is the current status of trial NCT05181215?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2021-05-14. Estimated completion is 2021-08-27.
What interventions are being tested in trial NCT05181215?
The interventions under investigation include: Monomethyl Fumarate 190 Mg (DRUG), Diroximel Fumarate 462 mg (DRUG).
Who is sponsoring clinical trial NCT05181215?
This trial is sponsored by Banner Life Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05181215's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01890590 · 46 participants · NA
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
- NCT03191149 · 46 participants · Phase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
- NCT03510208 · 46 participants · Phase 1
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
- NCT04048278 · 46 participants · Early Phase 1
Lidocaine Infusion in Pancreatic Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI