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NCT Number: NCT01240187

A Study to Demonstrate Bioequivalence Between 6 x 2 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.

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Key information

Conditions

Partial Onset Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Edinburgh, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

perampanel

Drug

Single dose of 6 tablets 2 mg orally

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 15, 2010
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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