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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01240187

Enrollment

Registered

2010-11-15

Start date

2010-06-30

Completion date

2010-09-30

Last updated

2013-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Onset Epilepsy

Keywords

epilepsy

Brief summary

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.

Detailed description

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

Interventions

DRUGperampanel

Single dose of 6 tablets 2 mg orally

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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.	12 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026