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Sumatriptan

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment112

FDA Designations

No designations recorded

Clinical trial landscape

Sumatriptan · 2 trials · 1 indication

Phase 1 2
NCT00648466Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mgHealthy
COMPLETED55 Analytics
NCT00650247Food Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mgHealthy
COMPLETED57 Analytics
PHASE1COMPLETED
Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg
Healthy
NCT0064846655
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PHASE1COMPLETED
Food Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg
Healthy
NCT0065024757
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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 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 (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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Frequently asked questions about Sumatriptan

What is Sumatriptan used for?

Sumatriptan is a small molecule drug being developed by Viatris Inc. (VTRS) for use in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials studying the drug in healthy individuals. The drug is not yet approved and remains investigational.

Who makes Sumatriptan?

Sumatriptan is being developed by Viatris Inc., which trades under the ticker VTRS. The company is conducting Phase 1 clinical trials of the drug in healthy volunteers. Viatris is responsible for the ongoing clinical development of Sumatriptan.

What phase is Sumatriptan in?

Sumatriptan is in Phase 1 clinical development. Two Phase 1 trials have been completed, both enrolling healthy volunteers. The drug is investigational and has not been approved by regulatory authorities. It remains in early-stage clinical testing.

What clinical trials is Sumatriptan in?

Sumatriptan has two completed Phase 1 trials: NCT00648466, a fasting study comparing Sumatriptan Succinate Tablets 100 mg to Imitrex Tablets 100 mg, and NCT00650247, a food study with the same comparison. Both trials enrolled healthy volunteers in the United States, with a total of 112 participants.

Is Sumatriptan the same as Imitrex?

Sumatriptan is being studied as a generic version of Imitrex. The clinical trials compare Sumatriptan Succinate Tablets 100 mg to Imitrex Tablets 100 mg, indicating that Sumatriptan is intended to be a bioequivalent alternative to the brand-name drug Imitrex.