Bioequivalence Trial of Alprazolam 0.25 mg Tablets

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Anxiety Disorders

Clinical Trial Details

NCT number	NCT01853956
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 1
Start date	December 2, 2010
Completion date	December 10, 2010

View Details

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