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The primary objective of this study is to establish the bioequivalence of the test product (BG00012 [dimethyl fumarate] supplied by Biogen Idec OSD) to the reference product (BG00012 supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers.
The secondary objectives of this study are to determine the safety and tolerability of the test product compared to the reference product, to estimate PK parameters of the test product and the reference product, and to estimate the intra-subject coefficient of variation (CV%) of the referenced product for both area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate - Reference form | Drug | single dose 240 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012 | Up to 48 hours following each dose administration | |
| Maximum observed concentration (Cmax) of BG00012 | Up to 48 hours following each dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to Day 13 | |
| Area under the plasma concentration curve from time of dosing to 48 hours | Up to 48 hours following each dose administration |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Daytona Beach | Florida | 32117 | United States | ||
| Research Site |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| dimethyl fumarate - Test form | Drug | single dose 240 mg |
|
|
| Apparent clearance (CL/F) | Up to 48 hours following each dose administration |
| Time to peak plasma concentration (Tmax) | Up to 48 hours following each dose administration |
| Lag time (tlag) | Up to 48 hours following each dose administration |
| Half-life (t1/2) | Up to 48 hours following each dose administration |
| Intra-subject coefficient of variation (CV%) of the reference product for area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax) | Up to 48 hours following each dose administration |
| Evansville |
| Indiana |
| 47710 |
| United States |
| D009930 |
| Organic Chemicals |