At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Alprazolam Extended-Release 3 mg Tablets +1 moredrug
Likely dose
Alprazolam Extended-Release 3 mg Tabletsfrom 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 3 mg Alprazolam Extended Release Tablets Under Non-fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Alprazolam Extended-Release 3 mg Tablets for Healthy. Completed, enrolled 36 participants across 2 sites.
Detailed Summary
This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA with that of 3 mg XANAX XR® Tablets by Pharmacia \& Upjohn Company following a single oral dose (1 x 3 mg extended release tablet) in healthy adult subjects administered under non-fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
Primary CompletionJun 2005
First PostedJan 2009
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartJun 1, 2005
Primary CompletionJun 1, 2005
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Alprazolam Extended-Release 3 mg Tabletsdrug
1 x 3 mg, single dose non-fasting
Alprazolam Extended-Release 3 mg Tabletsdrug
1 x 3 mg, single dose non-fasting