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Lamotrigine

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

Lamotrigine · 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
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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
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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
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