Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

• Status: Completed
• Trial end date: 2018-03-09
• Target enrollment: 0
• Participant gender: All

Summary

This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Co., Ltd.

Criteria

Inclusion Criteria

Participants must meet all of the following criteria to be included in this study:

• Non-smoking, male or female age ≥20 years and ≤45 years old at the time of obtaining written informed consent. To be considered non-smokers, participants must have discontinued smoking from Screening before first dosing.

• Body Mass Index ≥18.5 and <25.0 kilograms per meters squared at Screening

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from this study:

• Females who are breastfeeding or pregnant at Screening or Baseline

• Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing

• Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing

• Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening

• Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening

• A prolonged QT/QT corrected interval (QT interval, Fridericia correction >450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline