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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00647894 | Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mg | PHASE1 | COMPLETED | 24 | — | — | Jan 1, 2005 | Jan 1, 2005 | Apr 24, 2024 | 1 | United States |
| NCT00647634 | Fasting Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg | PHASE1 | COMPLETED | 21 | — | — | Aug 1, 2004 | Aug 1, 2004 | Apr 24, 2024 | 1 | United States |
| NCT00650299 | Fed Study of Alprazolam Extended-release Tablets 3 mg to Xanax XR® Tablets 3 mg | PHASE1 | COMPLETED | 21 | — | — | Aug 1, 2004 | Aug 1, 2004 | Apr 24, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Alprazolam Extended-Release Tablets 1 mg |
| 2 | ACTIVE_COMPARATOR | Xanax XR Tablets 1 mg |
| Name | Type | Description |
|---|---|---|
| Alprazolam Extended-Release Tablets 1 mg | DRUG | - |
| Xanax XR Tablets 1 mg | DRUG | - |
| Alprazolam Extended-Release Tablets 3 mg | DRUG | 3mg, single dose fasting |
| Xanax XR® Tablets (3 mg | DRUG | 3mg, single dose fasting |
| Xanax XR® Tablets 3 mg | DRUG | 3mg, single dose fed |
Inclusion Criteria: * 1\. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ...