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Label indication TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use : Use only if a clear diagnosis of migraine has been established ( 1 ) Not indicated for the preventive treatment of migraine ( 1 ) Not indicated for the treatment… FDA label
Also known as Imitrex
Sumatriptan · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sumatriptan Succinate tablets 100 mg | EXPERIMENTAL | Sumatriptan Succinate tablets 100 mg of Dr.Reddy's Laboratories Limited |
| Imitrex 100 mg Tablets | ACTIVE_COMPARATOR | Imitrex 100 mg Tablets of Glaxosmithkline |
| Name | Type | Description |
|---|---|---|
| Sumatriptan | DRUG | Sumatriptan Succinate Tablets 100 mg |
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...
Sumatriptan is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied in a Phase 1 clinical trial. The specific medical conditions it is intended to treat have not been disclosed.
Sumatriptan targets the HTR1B and HTR1D receptors, where it acts as an agonist. By activating these receptors, it is designed to produce its pharmacological effects. This mechanism is being evaluated in clinical development.
Sumatriptan is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company that trades under the ticker symbol RDY. The company is responsible for the clinical program, including the Phase 1 trial of the drug.
Sumatriptan is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 trial has been completed, and no active trials are currently listed.
Sumatriptan has been studied in one completed Phase 1 trial, NCT01269281, titled "Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions." The trial enrolled 50 healthy male volunteers in India and used an active-controlled, randomized design.