At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 42 enrolled
Drug / intervention
Zaleplon 10 mg Capsules +1 moredrug
Likely dose
Zaleplon 10 mg Capsulesfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Relative Bioavailability Study of Zaleplon 10 mg Capsules Under Non-Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Zaleplon 10 mg Capsules and SONATA® 10 mg capsules for Healthy. Completed, enrolled 42 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2004
Primary CompletionMar 2004
First PostedJan 2009
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartFeb 1, 2004
Primary CompletionMar 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Zaleplon 10 mg Capsulesdrug
1 x 10 mg
SONATA® 10 mg capsulesdrug
1 x 10 mg