Status:
COMPLETED
Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Healthy Participants
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03399734
Start Date
December 18 2017
End Date
March 9 2018
Last Update
October 29 2018
Active Locations (1)
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1
Eisai Trial Site
Toshima-ku, Tokyo, Japan