At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 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 10mg Capsules Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Zaleplon 10 mg Capsules and Sonata® 10 mg Capsules for Healthy. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2004
Primary CompletionFeb 2004
First PostedJan 2009
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartFeb 1, 2004
Primary CompletionFeb 1, 2004
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Zaleplon 10 mg Capsulesdrug
1 x 10 mg, single-dose fasting
Sonata® 10 mg Capsulesdrug
1 x 10 mg, single-dose fasting