Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test formulation administered with water · 1 trial · 1 indication
| 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...
It is an investigational controlled-release oxycodone formulation developed by Pfizer. It was studied in a Phase 1 trial to determine how co-administration of alcohol affects the absorption of oxycodone from the proprietary controlled-release formulation.
Pfizer, Inc. (ticker PFE) is the developer of the test formulation administered with water. The company sponsored the Phase 1 clinical trial evaluating the formulation.
The test formulation administered with water is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, with no active trials ongoing.
The test formulation administered with water was evaluated in NCT01677039, titled Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation. The Phase 1 trial was completed, enrolled 19 healthy volunteers in the United States, and used an active-controlled, randomized design.
The test formulation administered with water was studied in healthy volunteers to assess how co-administration of alcohol affects the absorption of oxycodone from the proprietary controlled-release formulation. The Phase 1 trial enrolled 19 participants aged 21 years and older in the United States.