Healthy Subjects Clinical Trial
Official title:
A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence between the oral suspension and tablet formulations of perampanel will be evaluated under fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet formulations will be evaluated under fed conditions. In both study arms, subjects will be randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for perampanel as either oral suspension or a tablet, and will then receive the alternative treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a washout of at least 6 weeks between the two treatment periods.
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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