Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lamotrigine Dispersible/Chewable · 2 trials · 1 indication
AUC(0-inf) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-inf) is defined as area under the concentration vs. time curve from zero to infinity.
AUC(0-t) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-t) is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification.
| Arm | Type | Description |
|---|---|---|
| Lamotrigine Dispersable/Chewable | EXPERIMENTAL | lamotrigine dispersible/chewable tablet 100mg |
| Lamotrigine Compressed | EXPERIMENTAL | lamotrigine compressed tablet 100mg |
| Lamotrigine (Lamictal) D/C 5mg*5, Crossover | EXPERIMENTAL | Single dose of lamotrigine dispersible/chewable (D/C)5mg\*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg\*1 tablet at Day15 |
| Lamotrigine (Lamictal) Compressed 25mg, Crossover | EXPERIMENTAL | Single dose of lamotrigine compressed 25mg\*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day15 |
| Name | Type | Description |
|---|---|---|
| Lamotrigine Dispersible/Chewable tablet | DRUG | Single dose of lamotrigine dispersible/chewable 100mg tablet at Day1 |
| Lamotrigine Compressed tablet | DRUG | Single dose of lamotrigine compressed 100mg tablet at Day1 |
| Lamotrigine Dispersible/Chewable tablets 5mg*5 | DRUG | Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg\*1 tablet at Day15 |
| Lamotrigine Compressed tablet 25mg | DRUG | Single dose of lamotrigine compressed 25mg\*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day15 |
Inclusion Criteria: * Healthy Chinese male non-smoker, based on medical history and physical examination, aged between 18 and 45 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation inc...
Top 9 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Xenon Pharmaceuticals Inc. | XENE | 4 | PHASE3 | Azetukalner |
| Praxis Precision Medicines, Inc. | PRAX | 5 | PHASE3 | Vormatrigine, Elsunersen |
| Rapport Therapeutics, Inc. | RAPP | 3 | PHASE3 | RAP-219 |
| Supernus Pharmaceuticals, Inc. | SUPN | 4 | PHASE2 | SPN-817, BIS-001ER |
| Biohaven Ltd. | BHVN | 3 | PHASE2 | BHV-7000 |
| Harmony Biosciences Holdings, Inc. | HRMY | 1 | PHASE3 | Clemizole |
| Jazz Pharmaceuticals Public Limited Company | JAZZ | 3 | PHASE1 | CBD-OS, Epidiolex |
| Bright Minds Biosciences Inc. | DRUG | 1 | PHASE2 | BMB-101 |
| uniQure N.V. | QURE | 1 | PHASE1 | AMT-260 |
Lamotrigine Dispersible/Chewable is an oral formulation of lamotrigine developed by GSK plc for epilepsy. It is designed as a dispersible or chewable tablet, offering an alternative to standard compressed tablets. It is a small molecule and is currently in Phase 1 clinical development.
Lamotrigine Dispersible/Chewable is being developed for the treatment of epilepsy. The clinical trials conducted for this formulation have enrolled participants with epilepsy, though the studies were bioequivalence studies in healthy volunteers. It is intended to provide an alternative dosage form for patients who may have difficulty swallowing tablets.
Lamotrigine Dispersible/Chewable targets voltage-gated sodium channels, specifically SCN1A, SCN2A, SCN4A, SCN5A, SCN7A, and SCN9A. It acts as a blocker of these channels. This mechanism is consistent with its development for epilepsy, where sodium channel blockade helps stabilize neuronal membranes and reduce seizure activity.
Lamotrigine Dispersible/Chewable is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trials evaluating this formulation.
Lamotrigine Dispersible/Chewable is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The studies were bioequivalence studies comparing the dispersible/chewable formulation to compressed tablets.
Lamotrigine Dispersible/Chewable has been evaluated in two completed Phase 1 trials: NCT02064465, a bioequivalence study of the 100 mg dispersible/chewable tablet versus the 100 mg compressed tablet, and NCT01879423, a bioequivalence study of the 5 mg×5 dispersible/chewable tablet versus the 25 mg compressed tablet. Both enrolled healthy male volunteers in China.