NCT02279485

A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects

A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence between the oral suspension and tablet formulations of perampanel will be evaluated under fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet formulations will be evaluated under fed conditions. In both study arms, subjects will be randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for perampanel as either oral suspension or a tablet, and will then receive the alternative treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a washout of at least 6 weeks between the two treatment periods.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Perampanel

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2014-10-31
• Last updated: 2015-11-03