Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00835393 | Pantoprazole Sodium 40 mg DR Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 50 | — | — | Dec 1, 2003 | Dec 1, 2003 | Feb 3, 2009 | 2 | United States |
| NCT00835588 | Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 100 | — | — | Dec 1, 2003 | Dec 1, 2003 | Aug 20, 2024 | 2 | United States |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Pantoprazole | EXPERIMENTAL | Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period |
| Protonix® | ACTIVE_COMPARATOR | Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Pantoprazole Sodium 40 mg delayed-release tablets | DRUG | 1 x 40 mg |
| PROTONIX® 40 mg delayed-release tablets. | DRUG | 1 x 40 mg |
Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (Body Mass Index) of 30 or less. Exclusion Criteria: * Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or ser...