NCT00647634

Fasting Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Alprazolam Extended-Release Tablets (3 mg; Mylan) to Xanax XR® Tablets (3 mg; Pharmacia & Upjohn) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (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 3 mg Extended-release tablets to Pharmacia \& Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Alprazolam Extended-Release Tablets 3 mg	3mg, single dose fasting
DRUG	Xanax XR® Tablets (3 mg	3mg, single dose fasting

Timeline

• Start date: 2004-08-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States