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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01677039 | Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation | PHASE1 | COMPLETED | 19 | — | — | Sep 1, 2012 | Dec 1, 2012 | Dec 11, 2012 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Treatment A | ACTIVE_COMPARATOR | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Test formulation administered with water | DRUG | single dose of 20 mg of test formulation with 240 mL of water |
| Test formulation administered with 20% ethanol | DRUG | single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water |
| Test formulation administered with 40% ethanol | DRUG | single dose of 20 mg of test formulation with 240 mL of 40% ethanol |
Inclusion Criteria: * healthy volunteers * history of moderate alcohol consumption * total body weight exceeding 64 kg Exclusion Criteria: * history of clinically significant disease * history of sleep apnea * any condition affecting drug absorption * pregnant or nursing female subjects * history...