Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Perampanel

• Registration Number: NCT03399734
• Lead Sponsor: Eisai Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-18
• Status Verified: 2018-01
• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-16
• Primary Completion: 2018-03-09
• Study Completion: 2018-03-09
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Perampanel	4 milligrams (mg) perampanel tablet
Treatment B	Perampanel	4 mg perampanel fine granules

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time at which the highest drug concentration occurs (tmax)	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])	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
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.
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
Terminal elimination phase half-life (t1/2)	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
Mean residence time (MRT)	0-168 hours postdose of Treatment Period 1 and Treatment Period 2

Trial Locations

Locations (1)

Eisai Trial Site; 🇯🇵 Toshima-ku, Tokyo, Japan