Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: perampanel

• Registration Number: NCT01396577
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to determine that three 2-mg tablets of perampanel are bioequivalent to one 6-mg tablet of perampanel.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Status Verified: 2012-04
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3 x 2-mg perampanel	perampanel	-
6mg perampanel	perampanel	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
The incidence of AEs	8 days