An Open Label, Randomized, Two Treatment, Two Sequence, Two Period, Single Dose, Cross Over, Oral Bioequivalence Study of Perampanel 12mg Tablets of Abbott Laboratories De Colombia and Fycompa® (Perampanel 12mg) Tablets of Eisai Europe Limited in Healthy, Adult, Human Subjects Under Fasting Condition - Abstract
Background: Perampanel is a glutamate non-competitive receptor antagonist that is effective as adjunctive therapy for epilepsy. The main objective of the present research
is to compare the bioavailability and to evaluate the bioequivalence between the test and reference product. The secondary objective is to assess the safety and tolerability of the
drug. This drug when marketed will be cost effective medicine that can help patients with epilepsies.
Methods and findings: The study design was an open label, randomized, two treatment, two sequences, two period, single dose, cross over, oral bioequivalence study of the
two formulations in single dose of 12mg. The study was conducted in 28 healthy, adult, human subjects, aged between 22 to 44 years, under fasting conditions with a washout period
of 42 days in between doses. Blood samples were collected up to 72 hours post-dose for measurement of pharmacokinetic parameters in each period. Safety evaluation was done
by assessing clinical examinations, vital signs assessment, clinical laboratory parameters and monitoring subject’s well-being, symptoms and signs for adverse events. A validated
LC-MS/MS method was used to determine the plasma concentrations of Perampane l. Bioequivalence between both the products was established by calculating 90% confidence
intervals (90% CI) for the ratio of Cmax and AUC0-72 values for the test and reference products. The 90% confidence intervals found for the relation of Test/Reference were Cmax
87.57% - 105.93% and AUC0-72 89.06% - 98.82%.
Conclusion: According to FDA’s guidelines for Bioequivalence research, the confidence intervals for Cmax and AUC0-72 ranged between 80.00-125.00%. The above limits
obtained for Perampanel were within the accepted bio-equivalence limits. Thus, bio-equivalence was demonstrated between Perampanel 12mg Tablets of Abbott Laboratories de
Colombia and Fycompa® (Perampanel 12mg) tablets of Eisai Europe Limited in healthy, adult, human subjects under fasting conditions.