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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Partial Onset Epilepsy

Interventions

Type	Name	Description
DRUG	perampanel	Single dose of 6 tablets 2 mg orally
DRUG	perampanel	Single dose of 1 tablet 12 mg orally

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-11-15
• Last updated: 2013-05-14

Locations

1 site across 1 country: United Kingdom