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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00875784 | An Open-label, Randomized, 3-period Crossover Study to Evaluate Sumatriptan Pharmacokinetics for a TREXIMA™ (Sumatriptan Succinate / Naproxen Sodium) Tablet Followed by IMITREX® (Sumatriptan Succinate) | PHASE1 | COMPLETED | 30 | — | — | May 6, 2008 | Jun 14, 2008 | Aug 4, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| TREXIMA tablet followed by IMITREX injection (4mg) | EXPERIMENTAL | TREXIMA™ (sumatriptan succinate / naproxen sodium) Tablet followed by IMITREX® (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System® |
| TREXIMA tablet followed by IMITREX injection (6mg) | EXPERIMENTAL | TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System® |
| IMITREX tablet (100mg) | ACTIVE_COMPARATOR | IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet |
| Name | Type | Description |
|---|---|---|
| TREXIMA™ | DRUG | sumatriptan succinate / naproxen sodium tablet |
| IMITREX® (4mg) | DRUG | sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System® |
| IMITREX® (6mg) | DRUG | sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System® |
| IMITREX Tablet 100mg | DRUG | IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet |
Inclusion Criteria: * Healthy adult males and females between 18 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies and other tests. ...