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Zonisamide · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Zonisamide | EXPERIMENTAL | Zonisamide Capsules 100 mg of Dr.Reddy's laboratories Limited |
| Zonegran | ACTIVE_COMPARATOR | Zonegran Capsules 100 mg of EISAI INC |
| Name | Type | Description |
|---|---|---|
| Zonisamide | DRUG | Zonisamide capsules 100 mg |
| Zonegran | DRUG | Zonegran Capsules 100 mg of EISAI INC |
Inclusion Criteria: * Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate? * Is s/he at least 18 years of age? * Is his/her BMI between 19 and 30, inclusive? * Is s/he considered reliable and capable of understanding his/her responsibilit...
Zonisamide is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical trials. The specific medical conditions it is intended to treat have not been disclosed. It is not yet approved for any indication and remains an investigational therapy.
Zonisamide targets several sodium channel proteins, specifically SCN1A, SCN2A, SCN4A, SCN5A, SCN7A, and SCN9A. It acts as a blocker of these targets. By blocking these sodium channels, it modulates electrical signaling in cells, which is the basis of its pharmacological activity.
Zonisamide is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company traded under the ticker RDY. The company is responsible for the clinical development program, including the bioequivalence studies conducted in the United States.
Zonisamide is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently recruiting. The drug is investigational and has not been approved by the FDA for any indication.
Zonisamide has been evaluated in two completed Phase 1 bioequivalence trials: NCT01161979 under fed conditions and NCT01161966 under fasting conditions. Both trials enrolled 26 healthy adult volunteers in the United States and were active-controlled, randomized studies.