Back to resultsA Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
Primary Purpose
Partial Onset Epilepsy
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
perampanel
perampanel
Sponsored by
About this trial
This is an interventional treatment trial for Partial Onset Epilepsy focused on measuring epilepsy
Eligibility Criteria
Inclusion Criteria:
- Healthy male or female subjects aged between 18-55 years.
- BMI of 18-32 kg/m ^2.
- Willing and able to provide written informed consent.
Exclusion criteria:
- Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
- Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
- Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
- Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
- Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
- Subjects who consume more than five caffeinated beverages per day.
- Subjects who smoke more than 5 cigarettes per day.
- Subjects with a history of drug abuse or who have a positive urine drug screening test.
- Women who do not agree to use two methods of contraception.
Sites / Locations
- Quotient Clinical
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental 1
Experimental 2
Arm Description
Outcomes
Primary Outcome Measures
To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01240187
Brief Title
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Onset Epilepsy
Keywords
epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental 1
Arm Type
Experimental
Arm Title
Experimental 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
perampanel
Intervention Description
Single dose of 6 tablets 2 mg orally
Intervention Type
Drug
Intervention Name(s)
perampanel
Intervention Description
Single dose of 1 tablet 12 mg orally
Primary Outcome Measure Information:
Title
To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or female subjects aged between 18-55 years.
BMI of 18-32 kg/m ^2.
Willing and able to provide written informed consent.
Exclusion criteria:
Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
Subjects who consume more than five caffeinated beverages per day.
Subjects who smoke more than 5 cigarettes per day.
Subjects with a history of drug abuse or who have a positive urine drug screening test.
Women who do not agree to use two methods of contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Joanne Collier
Organizational Affiliation
Quotient Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Clinical
City
Edinburgh
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
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