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CompletedNCT01240187Updated May 14, 2013

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 Phase 1 interventional study of perampanel and perampanel in Partial Onset Epilepsy, sponsored by Eisai Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-14.

Sponsored by Eisai Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • Partial Onset Epilepsy

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Keywords

  • epilepsy
03

In context

Epilepsy

1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.

This study's enrollment of 22 is below the median of 50 across 1,228 interventional studies indexed under Epilepsy.

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Lead sponsor

Eisai Inc. is the lead sponsor of 368 studies on the registry; 7 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 56 (67%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Experimental 1

    Drug: perampanel

  • Experimental
    Experimental 2

    Drug: perampanel

Interventions

  • Drugperampanel

    Single dose of 6 tablets 2 mg orally

  • Drugperampanel

    Single dose of 1 tablet 12 mg orally

06

What researchers measure

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

07

Study locations

1 site
  • Quotient Clinical
    Edinburgh, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01240187
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Nov 15, 2010
Start date
Jun 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
May 14, 2013

Study contacts

Dr Joanne Collier
principal investigator · Quotient Clinical
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Perampanel

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Eisai Inc. →

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