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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00649480 | Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg | PHASE1 | COMPLETED | 60 | — | — | Jan 1, 2007 | Feb 1, 2007 | Apr 24, 2024 | 1 | United States |
| NCT00648531 | Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg | PHASE1 | COMPLETED | 80 | — | — | May 1, 2004 | May 1, 2004 | Apr 24, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | BALSALAZIDE DISODIUM CAPSULES, 750 MG |
| 2 | ACTIVE_COMPARATOR | COLAZAL® Capsules 750 mg |
| Name | Type | Description |
|---|---|---|
| BALSALAZIDE DISODIUM CAPSULES, 750 MG | DRUG | 3x750mg, single dose fed |
| COLAZAL® Capsules 750 mg | DRUG | 3x750mg, single dose fed |
| Balsalazide Disodium Capsules 750 mg | DRUG | 3x750mg, single dose fasting |
Inclusion Criteria: * Age:18 years and older * Sex: Male and/or non-pregnant, non-lactating female * Women of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to eac...