Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lamotrigine Chewable · 2 trials · 1 indication
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...