Bioequivalence Trial of Alprazolam 0.25 mg Tablets
Status:
Completed
Trial end date:
2010-12-10
Target enrollment:
Participant gender:
Summary
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.