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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00647621 | Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin® Kapseals® 100 mg | PHASE1 | COMPLETED | 72 | — | — | Oct 1, 2005 | Dec 1, 2005 | Apr 24, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Extended Phenytoin Sodium Capsules 100 mg |
| 2 | ACTIVE_COMPARATOR | Dilantin® Kapseals® 100 mg |
| Name | Type | Description |
|---|---|---|
| Extended Phenytoin Sodium Capsules 100 mg | DRUG | 3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16 |
| Dilantin® Kapseals® 100 mg | DRUG | 3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16 |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or females of non-childbearing potential. 1. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history: 1. postmenopausal with an absence of menses for ...