Bioequivalence Trial of Alprazolam 0.25 mg Tablets

The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. Test product was Zamoprax® 0.25 mg (GlaxoSmithKline) and reference product Tafil® 0.25 mg (Pharmacia \& Upjohn). One tablet 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 28 healthy volunteers, both genders, adults between 18-50 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.