Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02171208 | A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers | PHASE1 | COMPLETED | 80 | — | — | Jun 1, 2014 | Jul 1, 2014 | Jan 9, 2015 | 2 | United States |
| 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...