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This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.
This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of BG-00012 given in capsule form supplied by two different manufactures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Test product |
|
| 2 | Experimental | Reference product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product | Drug | Dimethyl Fumarate (BG00012) |
| |
| Reference product |
| Measure | Description | Time Frame |
|---|---|---|
| PK - Area under the plasma concentration curve. | Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours | |
| Peak plasma concentration as a measure of PK. | Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The number of AEs in participants as a measure of safety and tolerability. | Participants will be followed during the study, 4 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Minneapolis | Minnesota | United States |
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| Drug |
Dimethyl Fumarate (BG00012) |
|