NCT00647894

Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Alprazolam Extended-Release Tablets (1 mg; Mylan) to Xanax XR Tablets (1 mg; Pharmacia & Upjohn) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 1 mg Extended-release tablets to Pharmacia \& Upjohn's Xanax XR 1 mg tablets following a single, oral 3 mg (3 x 1 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Alprazolam Extended-Release Tablets 1 mg
DRUG	Xanax XR Tablets 1 mg

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States