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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02196662 | Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers | PHASE1 | COMPLETED | 30 | — | — | Jul 1, 2014 | Apr 1, 2015 | Apr 22, 2015 | 1 | Canada |
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | IBD98-M: mesalamine-sodium hyaluronate 200mg-28.75mg X2 |
| Treatment B | EXPERIMENTAL | IBD98-M without HA: Mesalamine 200mg X2 |
| Treatment C | EXPERIMENTAL | Delzicol 200 mg X2 |
| Name | Type | Description |
|---|---|---|
| IBD98-M: | DRUG | single adiministration |
| IBD98-M without HA | DRUG | single adiministration |
| Delzicol | DRUG | single adiministration |
Inclusion Criteria: 1. Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of age and older, with BMI \> 18.5 and \< 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females. 2. Healthy as defined by: * the absence of clinically significant illness ...