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Label indication TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in… FDA label
Also known as dimethyl fumarate - Reference form
dimethyl · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Reference, Test, Reference (RTR) | ACTIVE_COMPARATOR | Doses will be separated by a washout period |
| Test, Reference, Reference (TRR) | ACTIVE_COMPARATOR | Doses will be separated by a washout period |
| Name | Type | Description |
|---|---|---|
| dimethyl fumarate - Reference form | DRUG | single dose 240 mg |
| dimethyl fumarate - Test form | DRUG | single dose 240 mg |
Key Inclusion Criteria: * BMI of 19.0 to 30.0 kg/m2, inclusive * Subjects of reproductive potential must agree to practice effective contraception from at least 14 days prior to the first dose of study drug through at least 30 days after their last dose of study drug. Key Exclusion Criteria: * Hi...
Dimethyl fumarate - Reference form is a small molecule developed by Biogen Inc. (ticker BIIB). It is a reference form of dimethyl fumarate studied in a Phase 1 bioequivalence trial in healthy volunteers. Its therapeutic area is classified as Other, and no specific indication has been disclosed for this reference form.
Dimethyl fumarate - Reference form is developed by Biogen Inc., which trades under the ticker BIIB. Biogen is the sponsor of the clinical program for this reference form of dimethyl fumarate.
Dimethyl fumarate - Reference form is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. It is an investigational reference form and is not described as approved.
Dimethyl fumarate - Reference form has been studied in one completed Phase 1 trial, NCT02171208, titled a healthy volunteer study to establish the bioequivalence of BG00012 supplied by two different commercial manufacturers. The trial enrolled 80 healthy volunteers in the United States, was randomized, double blind, and active controlled.
Dimethyl fumarate - Reference form is also known as dimethyl fumarate - Reference form. It is a reference form of dimethyl fumarate, a small molecule, and is studied under the code BG00012 in its bioequivalence trial.