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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01550926 | A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms | PHASE1 | COMPLETED | 48 | — | — | Feb 1, 2009 | Mar 1, 2009 | Jan 28, 2013 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | 60 mg orlistat |
| Arm 2 | ACTIVE_COMPARATOR | 120 mg orlistat (2 X 60 mg capsules) |
| Arm 3 | EXPERIMENTAL | orlistat experimental formulation |
| Name | Type | Description |
|---|---|---|
| 120 mg orlistat | DRUG | 2 X60 mg capsule |
| 60 mg orlistat | DRUG | 60 mg orlistat |
| orlistat experimental dose | DRUG | experimental |
Inclusion Criteria: * age: 18-60 years * Body Mass Index: 25-33 Exclusion Criteria: * gastrointestinal disease * organ transplant * HIV, hepatitis B or C * food allergies * alcohol or other substance abuse * smoking