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The purpose of this study is to determine that six 2-mg tablets of perampanel are bioequivalent to one 12-mg tablet of perampanel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 x 2 mg perampanel | Active Comparator |
| |
| 12 mg Perampanel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | 6 x 2 mg perampanel once per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test) | 8 days | |
| AUC(0-t) of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test) | 8 days | |
| AUC(0-inf) of 6 x 2-mg perampanel tablets (ref) compared to that of the 12-mg perampanel tablet (test) | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of AEs | 8 days |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Cooper | Eisai Medical Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fargo | North Dakota | United States |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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| Perampanel |
| Drug |
12 mg perampanel once per day |
|