NCT00865761

A Relative Bioavailability Study of Alprazolam 3 mg ER Tablets Under Fasting Conditions

A Relative Bioavailability Study of 3 mg Alprazolam Extended Release Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the relative bioavailability of 3 mg Alprazolam Extended Release Tablets by Alpharma with that of 3 mg XANAX XR® Tablets by Pharmacia \& Upjohn Company following a single oral dose (1 x 3 mg extended-release tablet) in healthy adult volunteers administrated under fasting conditions.

Detailed description

Study Type: Interventional Study Design: Randomized, single-dose, two-way crossover study under fasting conditions. Official Title: A Relative Bioavailability Study of 3 mg Alprazolam Extended Release Tablets Under Fasting Conditions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Alprazolam 3 mg Extended Release Tablets, single dose	A: Experimental Subjects received Alpharma formulated products under fasting conditions
DRUG	XANAX XR® 3 mg tablets, single dose	B: Active comparator Subjects received Pharmacia \& Upjohn Company formulated products under fasting conditions

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States