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Sumatriptan

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Dec 1, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment112
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648466Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mgPHASE1 COMPLETED 55Nov 1, 2004Dec 1, 2004Dec 1, 20091 United States
NCT00650247Food Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mgPHASE1 COMPLETED 57Nov 1, 2004Dec 1, 2004Dec 1, 20091 United States
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Study Endpoints
Primary Endpoints
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
Blood collections through 16 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALSumatriptan Succinate Tablets 100 mg
2ACTIVE_COMPARATORImitrex® Tablets 100 mg
Interventions
NameTypeDescription
Sumatriptan Succinate Tablets 100 mgDRUG100mg, single dose fasting
Imitrex® Tablets 100 mgDRUG100mg, single dose fasting
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Eligibility Criteria
Age Range18 Years — 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 (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ev...

Countries:United States
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