Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04570670
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
2020-09-22
Brief Title:
Comparative Bioavailability of BAFIERTAM Monomethyl Fumarate and Tecfidera Dimethyl Fumarate in Healthy Subjects
Sponsor:
Banner Life Sciences LLC
Organization:
Banner Life Sciences LLC
Study Overview
Official Title:
A Single-Dose Randomized Open-Label 2-Way Crossover Comparative Bioavailability Study of BLS-11 Monomethyl Fumarate 190 mg and Tecfidera Dimethyl Fumarate 240 mg in Healthy Male and Female Subjects Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study was to assess the bioequivalence of the test product Bafiertam BLS-11 monomethyl fumarate 190 mg versus Tecfidera dimethyl fumarate 240 mg based on the Cmax and Area Under the Curve AUC values of monomethyl fumarate MMF determined after a single dose under fasting conditions
Detailed Description:
This was a single-dose open-label randomized 2-way crossover study evaluating the comparative pharmacokinetics of the test product MMF versus the reference product DMF under fasting conditions Fifty 50 healthy adult male and non-pregnant female subjects were enrolled Screening of subjects occurred within 21 days prior to the first dose Subjects were randomized to 1 of 2 treatment sequences prior to the first dose
In each period subjects received a single oral dose of MMF 190 mg administered as two 95 mg delayed-release capsules test product or Tecfidera 240 mg DMF delayed-release capsule reference product followed by blood sampling including predose samples up to 24 hours postdose for the determination of plasma concentrations of MMF There was a washout period of 2 days between the 2 doses
Safety was monitored throughout the study by repeated clinical and laboratory evaluations
In each period subjects received a single oral dose of MMF 190 mg administered as two 95 mg delayed-release capsules test product or Tecfidera 240 mg DMF delayed-release capsule reference product followed by blood sampling including predose samples up to 24 hours postdose for the determination of plasma concentrations of MMF There was a washout period of 2 days between the 2 doses
Safety was monitored throughout the study by repeated clinical and laboratory evaluations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None