The objective of this study was to confirm if two formulations of gabapentin (capsules) are
bioequivalent.
Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product
Nerotin® 300 mg (Pfizer). One capsule was the single dosage.
The study was prospective, open-label, randomized, crossover, single dose, with 02
treatments, 02 sequences and 02 periods, under fasting conditions.
The population was composed of 26 healthy volunteers, both genders, adults between 18-55
years.
The comparative bioavailability of the two formulations was evaluated based in statistical
comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
in blood.