A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

May 13, 2013 updated by: Eisai Inc.

A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 6 x2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female subjects aged between 18-55 years.
  • BMI of 18-32 kg/m ^2.
  • Willing and able to provide written informed consent.

Exclusion criteria:

  • Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
  • Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
  • Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
  • Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
  • Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
  • Subjects who consume more than five caffeinated beverages per day.
  • Subjects who smoke more than 5 cigarettes per day.
  • Subjects with a history of drug abuse or who have a positive urine drug screening test.
  • Women who do not agree to use two methods of contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental 1
Drug: perampanel
Single dose of 6 tablets 2 mg orally
Drug: perampanel
Single dose of 1 tablet 12 mg orally
Experimental: Experimental 2
Drug: perampanel
Single dose of 6 tablets 2 mg orally
Drug: perampanel
Single dose of 1 tablet 12 mg orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Principal Investigator: Dr Joanne Collier, Quotient Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 15, 2010

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2007-E044-037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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