Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00649714 | Fed Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg | PHASE1 | COMPLETED | 110 | — | — | Dec 1, 2003 | Jan 1, 2004 | Apr 23, 2024 | 1 | United States |
| NCT00650052 | Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg | PHASE1 | COMPLETED | 107 | — | — | Nov 1, 2003 | Dec 1, 2003 | Apr 23, 2024 | 1 | United States |
| 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 ...