Overview

Bioequivalence Trial of Alprazolam 2 mg Tablets

Status:
Completed
Trial end date:
2010-04-05
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® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 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 26 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.
Phase:
Phase 1
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Alprazolam