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Trial record 42 of 948 for:    tablet | Japan

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

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ClinicalTrials.gov Identifier: NCT03399734
Recruitment Status : Completed
First Posted : January 16, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Perampanel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : March 9, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Perampanel

Arm Intervention/treatment
Experimental: Treatment A
4 milligrams (mg) perampanel tablet
Drug: Perampanel
Single oral dose of 1 x 4-mg perampanel tablet
Other Name: E2007

Experimental: Treatment B
4 mg perampanel fine granules
Drug: Perampanel
Single 4-mg dose of perampanel fine granules
Other Name: E2007




Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) [ Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 ]
  2. Area under the concentration-time curve from zero time to 168 hours (AUC[0-168h]) [ Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 ]

Secondary Outcome Measures :
  1. Time at which the highest drug concentration occurs (tmax) [ Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 ]
  2. Lag time (tlag) [ Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 ]
    tlag is the time delay between drug administration and the onset of drug absorption.

  3. Area under the concentration-time curve from zero time to 72 hours (AUC[0-72h]) [ Time Frame: 0-72 hours postdose of Treatment Period 1 and Treatment Period 2 ]
  4. Area under the concentration-time curve from zero time to time of the last quantifiable concentration (AUC[0-t]) [ Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 ]
  5. Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) [ Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 ]
  6. Terminal phase rate constant (λz) [ Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 ]
  7. Terminal elimination phase half-life (t1/2) [ Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 ]
  8. Mean residence time (MRT) [ Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399734


Locations
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Japan
Eisai Trial Site
Toshima-ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03399734     History of Changes
Other Study ID Numbers: E2007-J081-053
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Perampanel
Bioequivalence
fine granules
E2007
Japanese