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Lamotrigine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 28, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials8
Total Enrollment284

FDA Designations

No designations recorded

Clinical trial landscape

Lamotrigine · 8 trials · 1 indication

Phase 1 8
NCT01888757Lamotrigine Extended-Release Tablets 50 mg Under Fed ConditionHealthy
COMPLETED62 Analytics
NCT01888250Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting ConditionHealthy
COMPLETED36 Analytics
NCT01888263Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed ConditionHealthy
COMPLETED32 Analytics
NCT01888731Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting ConditionHealthy
COMPLETED62 Analytics
NCT01131949Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fasting ConditionHealthy
COMPLETED26 Analytics
NCT01131975Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed ConditionHealthy
COMPLETED26 Analytics
NCT01513720Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting ConditionHealthy
COMPLETED20 Analytics
NCT01513681Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed ConditionHealthy
COMPLETED20 Analytics
PHASE1COMPLETED
Lamotrigine Extended-Release Tablets 50 mg Under Fed Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under curve(AUC)
Predose (0.00) and 1.00, 2.00, 3.00, 4.50, 6.00, 7.50, 9.00, 10.50, 12.00, 13.50, 15.00, 16.50, 18.00, 20.00, 22.00, 24.00, 26.00, 30.00, 36.00, 48.00, 72.00, 96.00, 120.00, 144.00 and 168.00 post dose.
Bioequivalence based on Cmax and AUC parameters
3 months
Area under curve (AUC)
Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lamotrigine Extended Release TabletsEXPERIMENTALLamotrigine Extended Release Tablets, 25 mg, 50 mg, 100 mg, 200 mg and 300 mgof Dr. Reddy's Laboratories Limited
LAMICTAL XRACTIVE_COMPARATOR(containing Lamotrigine)Extended Release tablets 50 mg of GlaxoSmithKline Research Triangle Park, NC
Lamotrigine (chewable, dispersible)EXPERIMENTALLamotrigine Tablets (chewable, dispersible),25 mg of Dr. Reddy's Laboratories Limited
LamictalACTIVE_COMPARATORLamictal Tablets 25 mg of Glaxo SmithKline
Lamotrigine Tablets 200 mgEXPERIMENTALLamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited
Lamictal® 200 mg TabletsACTIVE_COMPARATORLamictal® 200 mg Tablets of GlaxoSmithKline Inc

Interventions

NameTypeDescription
LamotrigineDRUGLamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Lamictal®DRUGLamictal® 200 mg Tablets
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects were selected based on the following inclusion criteria: * Provide written informed consent. * Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg. * Having a body mass index between 18.5 and 24.9 (both inclusive)...

Countries:IndiaUnited States
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