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...
Lamotrigine Chewable is a chewable tablet formulation of lamotrigine, a small molecule drug developed by Teva Pharmaceutical Industries Limited under the ticker TEVA. It is being studied in Phase 1 clinical trials. The specific therapeutic indications for this chewable formulation have not been disclosed.
Lamotrigine Chewable targets voltage-gated sodium channels, specifically SCN1A, SCN2A, SCN4A, SCN5A, SCN7A, and SCN9A. It acts as a blocker of these channels. This target profile is consistent with the known mechanism of lamotrigine, which modulates neuronal sodium channel activity.
Lamotrigine Chewable is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. Teva is the sponsor responsible for the clinical development of this chewable tablet formulation of lamotrigine.
Lamotrigine Chewable is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA for any indication. The Phase 1 program consists of two completed trials with a total enrollment of 64 participants.
Lamotrigine Chewable has been evaluated in two completed Phase 1 trials: NCT00838279, titled Lamotrigine 25 mg Chewable Tablets, Fasting, and NCT00838136, titled Lamotrigine 25 mg Chewable Tablets, Non-Fasting. Both trials enrolled 32 healthy adult volunteers in Canada and used an active-controlled, randomized design.