Zaleplon 10 mg Capsules Under Non-Fasting Conditions

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.

Timeline

Start

2004-02

Primary completion

2004-03

Completion

2004-03

Outcome

Met primary endpoint

registry Ratio of Geometric Means 109 (90% CI 99.3 to 120) NCT00829868 ↗

registry Ratio of Geometric Means 101 (90% CI 97.5 to 106) NCT00829868 ↗

registry Ratio of Geometric Means 100 (90% CI 96.2 to 104) NCT00829868 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zaleplon	Small molecule	10 mg	—

Indications

No indication recorded.