NCT01322867

A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets

A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	alprazolam tablet	0,25 mg oral tablets given once
DRUG	alprazolam oral solution	0,75 mg/ml Oral Solution (Drops) given once

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-03-25
• Last updated: 2021-01-28

Locations

1 site across 1 country: Brazil