Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PROTONIX · 2 trials · 1 indication
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...
PROTONIX is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and the therapeutic area is classified as Other. Two Phase 1 trials have been completed with a total enrollment of 150 participants.
PROTONIX is being studied for use in healthy volunteers. The clinical trials are focused on evaluating the drug in non-patient populations. The specific indication is listed as Healthy, meaning the studies are not targeting a particular disease condition. The drug is in early-stage clinical development.
PROTONIX is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials for this drug. As of the latest data, PROTONIX is in Phase 1 development, with two completed trials in healthy volunteers.
PROTONIX is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both in healthy volunteers. The trials were active-controlled and randomized, but not double-blind.
PROTONIX has two completed Phase 1 trials. NCT00835393 studied Pantoprazole Sodium 40 mg DR Tablets under non-fasting conditions with 50 participants. NCT00835588 studied the same drug under fasting conditions with 100 participants. Both trials were conducted in the United States with healthy volunteers aged 18 years and older.
PROTONIX is a brand name for the drug pantoprazole. The clinical trials for PROTONIX are titled 'Pantoprazole Sodium 40 mg DR Tablets,' indicating that the active ingredient is pantoprazole sodium. The drug is being developed by Teva Pharmaceutical Industries Limited and is currently in Phase 1 trials.