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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00648934 | Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg | PHASE1 | COMPLETED | 36 | — | — | Nov 1, 2005 | Dec 1, 2005 | Apr 23, 2024 | 1 | United States |
| NCT00649467 | Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg | PHASE1 | COMPLETED | 35 | — | — | Nov 1, 2005 | Dec 1, 2005 | Apr 23, 2024 | 1 | United States |
| NCT00649740 | Fasting Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg | PHASE1 | COMPLETED | 36 | — | — | Nov 1, 2005 | Dec 1, 2005 | Apr 23, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Topiramate Sprinkle Capsules 25 mg |
| 2 | ACTIVE_COMPARATOR | Topamax® Sprinkle Capsules 25 mg |
| Name | Type | Description |
|---|---|---|
| Topiramate Sprinkle Capsules 25 mg | DRUG | 25mg, single dose fed |
| Topamax® Sprinkle Capsules 25 mg | DRUG | 25mg, single dose fed |
| Topamax® Sprinkle Capsule 25 mg | DRUG | 25mg, single dose fasting |
Inclusion Criteria: * healthy, adult subjects, 18 years and older * able to swallow medication Exclusion Criteria: * institutionalized subjects * history of any significant disease * use of any prescription or OTC medications within 14 days of start of study * received any investigational product...