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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Partial Onset Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental 1

Group Type EXPERIMENTAL

perampanel

Intervention Type DRUG

Single dose of 6 tablets 2 mg orally

Experimental 2

Group Type EXPERIMENTAL

perampanel

Intervention Type DRUG

Single dose of 1 tablet 12 mg orally

Interventions

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perampanel

Single dose of 6 tablets 2 mg orally

Intervention Type DRUG

perampanel

Single dose of 1 tablet 12 mg orally

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes