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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00840203 | Mesalamine 4 gm/60 mL Rectal Enema | PHASE1 | COMPLETED | 72 | — | — | May 1, 2003 | Jun 1, 2003 | Aug 19, 2024 | 1 | United States |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Mesalamine | EXPERIMENTAL | Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period |
| Rowasa® | ACTIVE_COMPARATOR | Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Rowasa® 4 gm/60 mL Rectal Enema | DRUG | 1 x 4 gm/60 mL, single-dose |
| Mesalamine 4 gm/60 mL Rectal Enema | DRUG | 1 x 4 gm/60 mL, single-dose |
Inclusion Criteria: * Males and females, 18 years or older, with a body mass index (BMI) of 30 or less. * Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. * Signed informed consent form, which meets all criteria of current FDA r...