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.
A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Single dose of 6 tablets 2 mg orally
Single dose of 1 tablet 12 mg orally
Quotient Clinical
Edinburgh, United Kingdom
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
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