Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00835588 · ClinicalTrials.gov registry record · Phase 1
Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT00835588: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00835588 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835588, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
Bioequivalence based on Cmax
Interventions
- DRUG Pantoprazole Sodium 40 mg delayed-release tablets
- DRUG PROTONIX® 40 mg delayed-release tablets.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2003-12 |
| Est. Completion | 2003-12 |
| Phase | Phase 1 |
What the finished NCT00835588 record still lists
NCT00835588 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 2 interventions - of which Pantoprazole Sodium 40 mg delayed-release tablets is the first listed.
NCT00835588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00835588 about?
NCT00835588 is a clinical study titled "Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions". 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 Hea...
What is the current status of trial NCT00835588?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2003-12. Estimated completion is 2003-12.
What interventions are being tested in trial NCT00835588?
The interventions under investigation include: Pantoprazole Sodium 40 mg delayed-release tablets (DRUG), PROTONIX® 40 mg delayed-release tablets. (DRUG).
Who is sponsoring clinical trial NCT00835588?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00835588's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia