At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 100 enrolled
Drug / intervention
Pantoprazole Sodium 40 mg delayed-release tablets +1 moredrug
Likely dose
Pantoprazole Sodium 40 mg delayed-release 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 Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Pantoprazole Sodium 40 mg delayed-release tablets and PROTONIX® 40 mg delayed-release tablets. for Healthy. Completed, enrolled 100 participants across 2 sites.
Detailed Summary
The objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PROTONIX® 40 mg delayed-released tablets (Wyeth-Ayerst) in Healthy, adult, non-smoking subjects under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2003
Primary CompletionDec 2003
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartDec 1, 2003
Primary CompletionDec 1, 2003
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Pantoprazole Sodium 40 mg delayed-release tabletsdrug
1 x 40 mg
PROTONIX® 40 mg delayed-release tablets.drug
1 x 40 mg