Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets
Public ClinicalTrials.gov record NCT01179646. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pharmacokinetic Study to Determine the Bioequivalence of a Test 40 mg Pantoprazole Delayed-Release Tablet, Compared to a Marketed 40 mg Pantoprazole Delayed-Release Tablet (Protonix, Wyeth Pharmaceuticals) When Administered to Healthy Adult Subjects in the Fasted State
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study was to determine the single-dose bioequivalence of the test product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared with the reference product, a pantoprazole 40 mg delayed-release tablet formulation (Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.
Study identification
- NCT ID
- NCT01179646
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 19 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2004
- Primary completion
- May 31, 2004
- Completion
- Jul 31, 2004
- Last update posted
- Aug 10, 2010
2004
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| MDS Pharma Services | Lincoln | Nebraska | 68502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01179646, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 10, 2010 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01179646 live on ClinicalTrials.gov.