NCT00652730

Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions

Comparative, Randomized, 3-Way Crossover Bioavailability Study of Par and Bristol-Myers Squibb (Buspar)15 mg Buspirone HCl Tablets Following Administration of a 30 mg Dose in Healthy Adult Males Under Fed and Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Par Pharmaceutical, Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets

Detailed description

To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg buspirone HCl tablets, following administration of a 30 mg dose, under fed conditions. In addition, the bioavailability of the Par product was compared under fed and fasting conditions.

Conditions

• To Determine Bioequivalence Under Fed Conditions

Interventions

Type	Name	Description
DRUG	Buspirone HCl	Tablets, 30 mg, single-dose, fasting conditions
DRUG	Buspirone HCl	Tablets, 30 mg, single-dose, fed conditions
DRUG	Buspar	Tablets, 30 mg, single-dose, fed conditions

Timeline

• Start date: 1998-07-01
• Primary completion: 1998-09-01
• Completion: 1998-09-01
• First posted: 2008-04-04
• Last updated: 2017-09-26

Locations

1 site across 1 country: Canada