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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00650000 | Fasting Study of Modafinil Tablets 200 mg and Provigil® Tablets 200 mg | PHASE1 | COMPLETED | 32 | — | — | Oct 1, 2002 | Oct 1, 2002 | Apr 24, 2024 | 1 | United States |
| NCT00650286 | Food Study of Modafinil Tablets 200 mg to Provigil® Tablets 200 mg | PHASE1 | COMPLETED | 20 | — | — | Sep 1, 2002 | Oct 1, 2002 | Apr 24, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Modafinil Tablets 200 mg |
| 2 | ACTIVE_COMPARATOR | Provigil® Tablets 200 mg |
| Name | Type | Description |
|---|---|---|
| Modafinil Tablets 200 mg | DRUG | 200mg, single dose fasting |
| Provigil® Tablets 200 mg | DRUG | 200mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administratio...