Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zonisamide · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Zonisamide Capsules 100 mg |
| 2 | ACTIVE_COMPARATOR | Zonegran® Capsules 100 mg |
| Name | Type | Description |
|---|---|---|
| Zonisamide Capsules 100 mg | DRUG | 100mg, single dose fed |
| Zonegran® Capsules 100 mg | DRUG | 100mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male. 3. Weight: At least 60 kg (132 lbs) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE ...
Zonisamide is a small molecule drug being developed by Viatris Inc. (VTRS). In the clinical trials listed, it is studied in healthy volunteers, not for a specific disease indication. The trials are bioavailability studies comparing Zonisamide capsules 100 mg to Zonegran capsules 100 mg.
Zonisamide is being developed by Viatris Inc., which trades under the ticker VTRS. The company is conducting Phase 1 clinical trials of the drug in the United States.
Zonisamide is in Phase 1 clinical development. It is an investigational drug and is not approved by the FDA. The two completed trials are early-stage bioavailability studies in healthy volunteers.
Zonisamide has two completed Phase 1 trials: NCT00649714, a fed study of Zonisamide capsules 100 mg versus Zonegran capsules 100 mg, and NCT00650052, a fasting study of the same comparison. Both enrolled healthy male volunteers aged 18 years and older in the United States.
Zonisamide is being studied as a generic version of Zonegran. The clinical trials compare Zonisamide capsules 100 mg to Zonegran capsules 100 mg to assess bioequivalence under fed and fasting conditions. Zonegran is the reference drug in these studies.