NCT00833521

Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions

A Relative BioAvailability Study of Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (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 Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle \& Co.) in healthy, adult, non-smoking subjects under fasting conditions.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zolpidem 10 mg tablets	1 x 10 mg
DRUG	AMBIEN® 10 mg tablets	1 x 10 mg

Timeline

• Start date: 2002-02-01
• Primary completion: 2002-02-01
• Completion: 2002-02-01
• First posted: 2009-02-02
• Last updated: 2024-08-21
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States