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This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.
This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Drug | Bioequivalence of two drug formulations |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration curve as a measure of PK. | Participants will be followed during the duration of the study, 4 days. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| The number of AEs in participants as a measure of safety and tolerability. | Participants will be followed during the time of study - an estimated four 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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