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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00647751 | Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg | PHASE1 | COMPLETED | 28 | — | — | Aug 1, 2004 | Aug 1, 2004 | Apr 24, 2024 | 1 | United States |
| NCT00650208 | Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg | PHASE1 | COMPLETED | 27 | — | — | Jul 1, 2004 | Aug 1, 2004 | Apr 24, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Lamotrigine Tablets 25 mg |
| 2 | ACTIVE_COMPARATOR | Lamictal® Tablets 25 mg |
| Name | Type | Description |
|---|---|---|
| Lamotrigine Tablets 25 mg | DRUG | 2x25mg, single dose fed |
| Lamictal® Tablets 25 mg | DRUG | 2x25mg, 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 (-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evenin...