Healthy Participants
Conditions
Keywords
Perampanel, Bioequivalence, fine granules, E2007, Japanese
Brief summary
This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.
Interventions
DRUGPerampanel
Single oral dose of 1 x 4-mg perampanel tablet
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all of the following criteria to be included in this study: * Non-smoking, male or female age ≥20 years and ≤45 years old at the time of obtaining written informed consent. To be considered non-smokers, participants must have discontinued smoking from Screening before first dosing. * Body Mass Index ≥18.5 and \<25.0 kilograms per meters squared at Screening
Exclusion criteria
Participants who meet any of the following criteria will be excluded from this study: * Females who are breastfeeding or pregnant at Screening or Baseline * Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing * Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing * Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening * Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening * A prolonged QT/QT corrected interval (QT interval, Fridericia correction \>450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 |
| Area under the concentration-time curve from zero time to 168 hours (AUC[0-168h]) | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration-time curve from zero time to 72 hours (AUC[0-72h]) | 0-72 hours postdose of Treatment Period 1 and Treatment Period 2 | — |
| Area under the concentration-time curve from zero time to time of the last quantifiable concentration (AUC[0-t]) | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | — |
| Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | — |
| Time at which the highest drug concentration occurs (tmax) | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | — |
| Terminal elimination phase half-life (t1/2) | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | — |
| Mean residence time (MRT) | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | — |
| Terminal phase rate constant (λz) | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | — |
| Lag time (tlag) | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | tlag is the time delay between drug administration and the onset of drug absorption. |
Countries
Japan
Outcome results
None listed