NCT00840606

Buspirone Hydrochloride 30mg Tablets, Fasting

A Relative Bioavailability Study of 30 mg Buspirone Hydrochloride Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (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 30 mg Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg tablet) in healthy adult volunteers under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BUSPAR® 30 mg Tablet	1 x 30 mg, single-dose fasting
DRUG	Buspirone Hydrochloride 30 mg Tablet	1 x 30 mg, single-dose fasting

Timeline

• Start date: 2001-12-01
• Primary completion: 2001-12-01
• Completion: 2002-04-01
• First posted: 2009-02-10
• Last updated: 2024-08-19

Locations

1 site across 1 country: United States