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This study will be conducted to evaluate the pharmacokinetics of perampanel following single and multiple oral doses in Chinese healthy male and female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perampanel single-dose Part: 2 mg group | Experimental | Participants will receive a single 2 milligrams (mg) dose of perampanel orally under fasted conditions. |
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| Perampanel single-dose Part: 4 mg group | Experimental | Participants will receive a single 4 mg dose of perampanel orally under fasted conditions. |
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| Perampanel single-dose Part: 8 mg group | Experimental | Participants will receive a single 8 mg dose of perampanel orally under fasted conditions. |
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| Perampanel multiple-dose Part | Experimental | Participants will receive multiple oral dose of perampanel (2 milligrams per day [mg/day] from Day 1 to Day 7 and 4 mg/day from Day 8 to Day 21). Fasted condition is required for Days 1 and 21. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Single-dose Part: Mean value of the maximum observed concentration (Cmax) postdose of perampanel | 0-336 hours postdose | |
| Single-dose Part: Mean value for the time at which the highest drug concentration occurs (tmax) postdose of perampanel | 0-336 hours postdose | |
| Single-dose Part: Mean value for area under the concentration-time curve from zero time to 24 hours (AUC[0-24h]) postdose of perampanel | 0-24 hours postdose | |
| Single-dose Part: Mean value for area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC[0-t]) postdose of perampanel | 0-336 hours postdose | |
| Single-dose Part: Mean value for area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) postdose of perampanel | 0-336 hours postdose | |
| Single-dose Part: Mean value for the terminal phase rate constant (λz) postdose of perampanel | 0-336 hours postdose | |
| Single-dose Part: Mean value for terminal elimination phase half-life (t1/2) postdose of perampanel | 0-336 hours postdose | |
| Single-dose Part: Mean value for apparent total clearance following oral administration (CL/F) postdose of perampanel | 0-336 hours postdose | |
| Single-dose Part: Mean value for the apparent volume of distribution at terminal phase (Vz/F) postdose of perampanel |
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Inclusion Criteria:
Participants must meet all of the following criteria to be included in this study:
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36746851 | Derived | Jing S, Shiba S, Morita M, Yasuda S, Lin Y. A Single- and Multiple-Dose Pharmacokinetic Study of Oral Perampanel in Healthy Chinese Subjects. Clin Drug Investig. 2023 Mar;43(3):155-165. doi: 10.1007/s40261-022-01241-8. Epub 2023 Feb 6. |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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|
| 0-336 hours postdose |
| Single-dose Part: Mean residence time (MRT) postdose of perampanel | 0-336 hours postdose |
| Multiple-dose Part: Mean value of Cmax postdose of perampanel on Day 1 | 0-24 hours postdose on Day 1 |
| Multiple-dose Part: Mean minimum observed concentration (Cmin) postdose of perampanel on Day 1 | 0-24 hours postdose on Day 1 |
| Multiple-dose Part: Mean tmax postdose of perampanel on Day 1 | 0-24 hours postdose on Day 1 |
| Multiple-dose Part: Mean AUC(0-24h) postdose of perampanel on Day 1 | 0-24 hours postdose on Day 1 |
| Multiple-dose Part: Mean value of area under the concentration-time curve over the dosing interval on multiple dosing (AUC[0-τ]) | 0-24 hours postdose of perampanel on Day 21 |
| Multiple-dose Part: Mean value of the average steady-state concentration (Css,av) postdose of perampanel on Day 21 | 0-24 hours postdose on Day 21 |
| Multiple-dose Part: Mean value of the maximum observed concentration at steady state (Css,max) postdose of perampanel on Day 21 | 0-24 hours postdose on Day 21 |
| Multiple-dose Part: Mean value of the minimum observed concentration at steady state (Css,min) postdose of perampanel on Day 21 | 0-24 hours postdose on Day 21 |
| Multiple-dose Part: Mean value of peak-trough fluctuation (PTF) postdose of perampanel on Day 21 | 0-24 hours postdose on Day 21 |
| Multiple-dose Part: Mean time at which the highest drug concentration occurs at steady state (tss,max) postdose of perampanel on Day 21 | 0-24 hours postdose on Day 21 |
| Multiple-dose Part: Mean time at which the lowest drug concentration between dosing intervals occurs at steady state (tss,min) postdose of perampanel on Day 21 | 0-24 hours postdose on Day 21 |
| Multiple-dose Part: Mean value of t1/2 postdose of perampanel on Day 21 | 0-336 hours postdose on Day 21 |
| Multiple-dose Part: Mean value of apparent total clearance following oral administration at steady state (CLss/F) postdose of perampanel on Day 21 | 0-24 hours postdose on Day 21 |
| Multiple-dose Part: Mean value of Vz/F postdose of perampanel on Day 21 | 0-336 hours postdose on Day 21 |
| Multiple-dose Part: Mean value of the accumulation ratio | 0-24 hours postdose of perampanel on Days 1 and 21 |