Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lamictal 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...
Lamictal Chewable is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA) for use in healthy volunteers. It is currently in Phase 1 clinical development, with studies focused on healthy individuals rather than a specific disease indication.
Lamictal Chewable is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials for this drug in healthy volunteers.
Lamictal Chewable is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy volunteers. Two Phase 1 trials have been completed, with no active trials currently ongoing.
Lamictal Chewable has two completed Phase 1 trials: NCT00838136, titled 'Lamotrigine 25 mg Chewable Tablets, Non-Fasting,' and NCT00838279, titled 'Lamotrigine 25 mg Chewable Tablets, Fasting.' Both enrolled 32 healthy volunteers each in Canada, with a total enrollment of 64 participants.
Lamictal Chewable is a chewable tablet formulation of lamotrigine, as indicated by the clinical trial titles. The trials study lamotrigine 25 mg chewable tablets under fasting and non-fasting conditions, confirming that Lamictal Chewable contains the active ingredient lamotrigine.