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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00774982 | Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients | PHASE1 | COMPLETED | 12 | — | — | Dec 1, 2008 | Feb 1, 2009 | Jul 17, 2009 | 1 | Israel |
| Arm | Type | Description |
|---|---|---|
| 1 6MP Test Formulation | EXPERIMENTAL | 1 x 40 mg Oral Tablet, 6 MP Delayed Release Test Formulation, for targeted ileal delivery |
| 2. 6MP Reference Formulation | ACTIVE_COMPARATOR | 2 x 50 mg oral tablet, PURINETHOL |
| Name | Type | Description |
|---|---|---|
| Delayed Release 6 mercaptopurine | DRUG | oral tablet, 1 x 40 mg Delayed Release 6MP tablet, single-dose |
| 6 Mercaptopurine | DRUG | Oral Tablet, 2 x 50 mg 6MP Reference, single-dose |
Inclusion Criteria: * 12 male and non-pregnant females, aged 18-50 years, with Crohns Disease (CDAI up to 200), non-smoking. Crohns Disease diagnosis via colonoscopy with biopsy within the past 12 years No CD medications allowed during study other than 5-ASA and symptomatic relief (anti-diarrheals...