Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lamotrigine IR tablets
Lamotrigine IR · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Subjects in Treatment regimen C | EXPERIMENTAL | Subjects in treatment regimen C will receive 200 milligram (mg) orally disintegrating tablets (ODT) of lamotrigine disintegrate in mouth without water in fasting condition. |
| Subjects in Treatment regimen D | EXPERIMENTAL | Subjects in treatment regimen D will receive 200 mg Immediate Release (IR) tablets of lamotrigine with water in fasting condition. |
| Subjects in Treatment regimen E | EXPERIMENTAL | Subjects in treatment regimen E will receive 200 mg ODT disintegrate of lamotrigine in mouth without water in fed state. |
| Subjects in Treatment regimen F | EXPERIMENTAL | Subjects in treatment regimen F will receive 200 mg ODT of lamotrigine, that subjects will swallow with water in fasting condition. |
| Name | Type | Description |
|---|---|---|
| Lamotrigine IR tablets | DRUG | Lamotrigine IR tablets will be available in dose strength of 200 mg. |
| Lamotrigine ODT tablets | DRUG | Lamotrigine ODT tablets will be available in dose strength of 200 mg. |
Inclusion Criteria: * Healthy male or female subjects aged 19 to 55 years inclusive * BMI within the range 19 to 32 kg/m2 inclusive. Exclusion Criteria: * Female subjects of childbearing potential will not be eligible if they are unwilling or unable to use an appropriate method of contraception a...
Lamotrigine IR is an immediate-release small molecule developed for mental disorders within the psychiatry therapeutic area. It is studied in a bioequivalence trial in healthy volunteers. The program is at Phase 1, so it remains investigational and is not approved for any indication based on the data available.
Lamotrigine IR targets sodium channel proteins SCN1A, SCN5A, SCN4A, SCN7A, SCN2A, and SCN9A. It acts as a blocker at these targets. This target class places it among small molecules that modulate sodium channel activity in the central nervous system.
Lamotrigine IR is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of the clinical program for this immediate-release formulation.
Lamotrigine IR is in Phase 1 development. The program has one completed Phase 1 trial and no active trials. It is investigational and has not been approved by the FDA for any indication based on the available information.
Lamotrigine IR has been studied in one completed Phase 1 trial, NCT00449774, titled Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers. The trial enrolled 220 healthy volunteers in the United States, was randomized and controlled, and included participants aged 19 years and older of all sexes.
Yes, Lamotrigine IR is also known as Lamotrigine IR tablets. The two names refer to the same immediate-release formulation developed by GSK plc for mental disorders.