NCT00829998

Zaleplon 10mg Capsules Under Fasting Conditions

A Relative Bioavailability Study of Zaleplon 10mg Capsules Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the relative bioavailability of Zaleplon 10 mg Capsules manufactured by TEVA Pharmaceuticals USA and Sonata® 10 mg Capsules manufactured by Wyeth Laboratories in healthy, non-smoking adults under fasting conditions.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zaleplon 10 mg Capsules	1 x 10 mg, single-dose fasting
DRUG	Sonata® 10 mg Capsules	1 x 10 mg, single-dose fasting

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2009-01-27
• Last updated: 2024-08-21
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States