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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01045967 | Lansoprazole 30 mg DR Capsule Fasting Study | PHASE1 | COMPLETED | 56 | — | — | May 1, 2004 | Jul 1, 2004 | Dec 8, 2010 | 1 | United States |
| NCT01046253 | Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study | PHASE1 | COMPLETED | 50 | — | — | Jan 1, 2004 | Jan 1, 2004 | Dec 8, 2010 | 1 | United States |
| NCT01046084 | Lansoprazole 30 mg DR Capsule Replicate Food Study | PHASE1 | COMPLETED | 50 | — | — | Aug 1, 2003 | Sep 1, 2003 | Dec 8, 2010 | 1 | United States |
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...