NCT00829868

Zaleplon 10 mg Capsules Under Non-Fasting Conditions

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under non-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
DRUG	SONATA® 10 mg capsules	1 x 10 mg

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-03-01
• Completion: 2004-03-01
• First posted: 2009-01-27
• Last updated: 2024-08-21
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States