Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
dimethyl- Reference form · 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 is an investigational small molecule being developed by Biogen Inc. (BIIB). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers to assess bioequivalence between two different commercial manufacturing sources.
Dimethyl fumarate is being studied for use in healthy volunteers. The ongoing clinical development focuses on establishing bioequivalence of the drug supplied by two different commercial manufacturers. It is an investigational drug and has not been approved for any indication.
Biogen Inc. (BIIB) is developing dimethyl fumarate. The company is conducting clinical trials to evaluate the drug in healthy volunteers. Biogen is the sponsor of the Phase 1 study assessing the bioequivalence of the drug from different manufacturing sources.
Dimethyl fumarate is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development.
Dimethyl fumarate is associated with one completed Phase 1 clinical trial, NCT02171208. This study, titled 'A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers,' enrolled 80 participants in the United States.
Yes, dimethyl fumarate is also known as BG00012. The clinical trial NCT02171208 references BG00012 as the drug being studied. This Phase 1 trial evaluates the bioequivalence of BG00012 supplied by two different commercial manufacturers in healthy volunteers.