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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Single oral dose of 1 x 4-mg perampanel tablet
Single 4-mg dose of perampanel fine granules
Eisai Trial Site
Toshima-ku, Tokyo, Japan
Maximum observed concentration (Cmax)
Time frame: 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])
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Time at which the highest drug concentration occurs (tmax)
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Lag time (tlag)
tlag is the time delay between drug administration and the onset of drug absorption.
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to 72 hours (AUC[0-72h])
Time frame: 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])
Time frame: 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])
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Terminal phase rate constant (λz)
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Terminal elimination phase half-life (t1/2)
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Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Mean residence time (MRT)
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2