NCT01188057

A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Non-Fasting Conditions

A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets Under Non-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

This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2 mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult volunteers administered under non-fasting conditions.

Detailed description

Study Type: Interventional Study Design: This was a single-center, randomized, two-way crossover study conducted under non-fasting conditions Official Title: A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets under Non-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 ORALLY DISINTEGRATING TABLETS, 2.0 MG	A: Experimental Subjects received Purepac Pharmaceutical Co. formulated products under non-fasting conditions
DRUG	NIRAVAM TM 2 mg orally disintegrating tablets, single dose	B: Active comparator Subjects received Schwarz Pharma Inc. formulated products non-under fasting conditions

Timeline

• Start date: 2006-07-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2010-08-25
• Last updated: 2010-08-25

Locations

1 site across 1 country: United States