NCT00829426

Alprazolam Extended-Release 3mg Tablets Bioequivalence Study 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: 32 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA 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 subjects administered under fasting conditions.

Detailed description

Detailed Description Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Alprazolam Extended-Release 3 mg Tablets	1 x 3 mg, single dose fasting
DRUG	Alprazolam Extended-Release 3 mg Tablets	1 x 3 mg, single dose fasting

Timeline

• Start date: 2005-06-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2009-01-27
• Last updated: 2024-09-19
• Results posted: 2009-07-21

Locations

2 sites across 1 country: United States