A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
NCT01240187 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2013-05-14
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.
Conditions
- Partial Onset Epilepsy
Interventions
- DRUG
-
perampanel
Single dose of 6 tablets 2 mg orally
- DRUG
-
perampanel
Single dose of 1 tablet 12 mg orally
Sponsors & Collaborators
-
Eisai Inc.
lead INDUSTRY
Principal Investigators
-
Dr Joanne Collier · Quotient Clinical
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2010-09-30
- Completion
- 2010-09-30
Countries
- United Kingdom
Study Locations
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