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Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy Subjects

NCT01396590 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-05-04

No results posted yet for this study

Summary

The purpose of this study is to determine that six 2-mg tablets of perampanel are bioequivalent to one 12-mg tablet of perampanel.

Conditions

  • Healthy

Interventions

DRUG

Perampanel

6 x 2 mg perampanel once per day

DRUG

Perampanel

12 mg perampanel once per day

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Cooper · Eisai Medical Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01396590 on ClinicalTrials.gov