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Sumatriptan

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 4, 2011

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 Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01269281Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed ConditionsPHASE1 COMPLETED 50Jul 1, 2005Jul 1, 2005Jan 4, 20111 India
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Study Endpoints
Primary Endpoints
Bioequivalence based on Cmax and AUCt and AUCi parameters
4 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sumatriptan Succinate tablets 100 mgEXPERIMENTALSumatriptan Succinate tablets 100 mg of Dr.Reddy's Laboratories Limited
Imitrex 100 mg TabletsACTIVE_COMPARATORImitrex 100 mg Tablets of Glaxosmithkline
Interventions
NameTypeDescription
SumatriptanDRUGSumatriptan Succinate Tablets 100 mg
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. The subjects should be healthy males between 18 and 45 years. 2. The subjects should be screened within 21 days prior to the administration of first dose of the study.. 3. The subjects should have a BMI between 18 and 25 kg/m2 4. The subjects should be able to communicate eff...

Countries:India
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