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Sumatriptan

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Sumatriptan · 1 trial · 1 indication

Phase 1 1
NCT01269281Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed ConditionsHealthy
COMPLETED50 Analytics
PHASE1COMPLETED
Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions
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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 to 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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Frequently asked questions about Sumatriptan

What is Sumatriptan used for?

Sumatriptan is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed bioequivalence study evaluating Sumatriptan Succinate Tablets 100 mg under fed conditions.

Who makes Sumatriptan?

Sumatriptan is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY.

What phase is Sumatriptan in?

Sumatriptan is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently ongoing.

What clinical trials is Sumatriptan in?

Sumatriptan has one completed clinical trial, NCT01269281, titled 'Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions'. This Phase 1 study enrolled 50 healthy male participants in India.

Is Sumatriptan FDA approved?

Sumatriptan is an investigational drug currently in Phase 1 clinical development. It has not been approved by the FDA, as it is still undergoing clinical trials.

What does Sumatriptan target?

Sumatriptan is a small molecule drug. Its specific molecular target has not been disclosed in the available clinical trial information.