Recent Updates
Recently added Catalysts

Lamictal

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

Lamictal · 2 trials · 1 indication

Phase 1 2
NCT00647751Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mgHealthy
COMPLETED28 Analytics
NCT00650208Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mgHealthy
COMPLETED27 Analytics
PHASE1COMPLETED
Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLamotrigine Tablets 25 mg
2ACTIVE_COMPARATORLamictal® Tablets 25 mg

Interventions

NameTypeDescription
Lamotrigine Tablets 25 mgDRUG2x25mg, single dose fed
Lamictal® Tablets 25 mgDRUG2x25mg, single dose fed
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evenin...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Lamictal

What is Lamictal?

Lamictal is a small molecule drug being developed by Viatris Inc. (ticker: VTRS). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and it is an investigational product, not yet approved for any indication.

What is Lamictal used for?

Lamictal is being studied for use in healthy volunteers. The current clinical trials are bioavailability studies comparing Lamictal tablets to a reference product. No therapeutic indication has been established for Lamictal in these trials, as they are focused on healthy participants.

Who makes Lamictal?

Lamictal is being developed by Viatris Inc., which trades under the ticker VTRS. The company is conducting Phase 1 clinical trials for Lamictal, which is a small molecule drug. Viatris is responsible for the ongoing clinical development of this investigational product.

What phase is Lamictal in?

Lamictal is in Phase 1 clinical development. There are two completed Phase 1 trials, and no active trials are currently ongoing. The drug is investigational and has not been approved by regulatory authorities. It is being studied in healthy volunteers.

What clinical trials is Lamictal in?

Lamictal has two completed Phase 1 clinical trials: NCT00647751, a food study of lamotrigine tablets 25 mg compared to Lamictal tablets 25 mg, and NCT00650208, a fasting study of the same comparison. Both trials enrolled healthy volunteers in the United States, with a total enrollment of 55 participants.

Is Lamictal the same as lamotrigine?

Lamictal is the brand name for lamotrigine. The clinical trials for Lamictal compare lamotrigine tablets to Lamictal tablets, indicating that lamotrigine is the active ingredient. Lamictal is the proprietary name used by the developer, Viatris Inc., for this small molecule drug.