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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00649285 | Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg | PHASE1 | COMPLETED | 71 | — | — | Oct 1, 2002 | Nov 1, 2002 | Apr 24, 2024 | 1 | United States |
| NCT01018342 | Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg | PHASE1 | COMPLETED | 80 | — | — | Jul 1, 2002 | - | Apr 23, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg |
| 2 | ACTIVE_COMPARATOR | Macrobid® Capsules 100 mg |
| Name | Type | Description |
|---|---|---|
| Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg | DRUG | 100mg, single dose fed |
| Macrobid® Capsules 100 mg | DRUG | 100mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum Beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to of the study and on the evening prior to e...