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

NCT03399734 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-10-29

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

Perampanel

Single oral dose of 1 x 4-mg perampanel tablet

DRUG

Perampanel

Single 4-mg dose of perampanel fine granules

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2018-03-09
Completion
2018-03-09

Countries

  • Japan

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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 NCT03399734 on ClinicalTrials.gov