Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lansoprazole · 3 trials · 1 indication
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| Invesigational Test Product | EXPERIMENTAL | Lansoprazole 30 mg delayed-release Capsules |
| Reference Listed Drug | ACTIVE_COMPARATOR | Prevacid® 30 mg delayed-release Capsules |
| Investigational Test Product | EXPERIMENTAL | Lansoprazole 30 mg Delayed-Release Capsule |
| Name | Type | Description |
|---|---|---|
| Lansoprazole | DRUG | 30 mg delayed-release Capsule |
| Prevacid® | DRUG | 30 mg delayed-release Capsule |
Inclusion Criteria: * Non-smokers or light smokers (10 or less cigarettes per day) * 18 years of age or older * Body Mass Index of 30 or less * Males or non-pregnant females * Normal clinical laboratory test results Exclusion Criteria: * Subjects with a significant history of chronic alcohol cons...
Lansoprazole is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is being studied in Phase 1 clinical development. The listed trials enrolled healthy adult volunteers rather than patients with a specific disease, and the studied indications are undisclosed.
Lansoprazole targets ATP4A and ATP4B. It acts as an inhibitor of these targets. ATP4A and ATP4B form the gastric proton pump, the enzyme complex responsible for secreting acid into the stomach, and inhibiting it reduces acid production.
Lansoprazole is developed by Teva Pharmaceutical Industries Limited, which is listed under the ticker TEVA. Teva is the sponsor associated with the clinical trials of lansoprazole included in this program, which cover Phase 1 studies conducted in the United States.
Lansoprazole is in Phase 1 clinical development. All three listed trials are Phase 1 studies, and all three are completed, with no active trials currently listed. The program has enrolled 156 participants in total across these studies.
Three completed Phase 1 trials of lansoprazole are listed: NCT01046253, a fasting replicate sprinkle study with 50 participants; NCT01046084, a replicate food study with 50 participants; and NCT01045967, a fasting study with 56 participants. All were conducted in the United States in healthy volunteers aged 18 years and older.
The lansoprazole trials were randomized and active controlled, and they were not double blind. They enrolled healthy adult volunteers of all sexes in the United States, with 156 participants across the three completed Phase 1 studies. No biomarker-based selection was used in these trials.