Uma Kuruganti
Tanzania
Research Article
Bioequivalence of Alprazolam Sublingual Tablet Formulation and
Alprazolam Immediate Release Tablet in Healthy Volunteers
Author(s): Bharat Damle , Sanela Tarabar , Uma Kuruganti , Penelope Crownover and Robert R LaBadieBharat Damle , Sanela Tarabar , Uma Kuruganti , Penelope Crownover and Robert R LaBadie
Alprazolam immediate release (IR) tablets are currently approved for the management of anxiety disorder or the short-term relief of symptoms of anxiety. A sublingual (SL) formulation of alprazolam, which disintegrates in the mouth without the need for additional fluids, has been developed. The aim of this study was to determine if the alprazolam SL 1 mg tablet was bioequivalent to the alprazolam IR 1 mg tablet in healthy volunteers. In this randomized, open label, two-way crossover, single dose study, subjects were randomized to receive a single alprazolam 1 mg IR tablet during one dosing period and a single 1 mg SL tablet during the other dosing period. The primary pharmacokinetic endpoints were area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration AUC (0-t) and maximum plasma concentration (C max ). Adverse events (AEs) we.. View More»
DOI:
10.4172/jbb.1000150