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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00838136 | Lamotrigine 25 mg Chewable Tablets, Non-Fasting | PHASE1 | COMPLETED | 32 | — | — | Feb 1, 2002 | Mar 1, 2002 | Aug 19, 2024 | 1 | Canada |
| NCT00838279 | Lamotrigine 25 mg Chewable Tablets, Fasting | PHASE1 | COMPLETED | 32 | — | — | Feb 1, 2002 | Mar 1, 2002 | Aug 19, 2024 | 1 | Canada |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Lamotrigine | EXPERIMENTAL | Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period |
| Lamictal® | ACTIVE_COMPARATOR | Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Lamotrigine 25 mg Chewable Tablets | DRUG | 2 x 25 mg, single-dose fed |
| Lamictal® 25 mg Chewable Tablets | DRUG | 2 x 25 mg, single-dose fed |
Inclusion Criteria: * Subjects will be females and/or males, non-smokers, 18 years of age and older. * Female subjects will be post-menopausal or surgically sterilized. * Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at lea...