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...
Test formulation administered with water is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to determine the effects of co-administering alcohol on the absorption of oxycodone from a proprietary controlled-release formulation. The drug is not approved and remains in clinical development.
Test formulation administered with water is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting a Phase 1 clinical trial of this investigational small molecule in healthy volunteers in the United States.
Test formulation administered with water is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 19 healthy volunteers.
Test formulation administered with water has one completed clinical trial, NCT01677039, titled "Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation." This Phase 1 study enrolled 19 healthy adults in the United States.
Test formulation administered with water is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT01677039, was a Phase 1 study in healthy volunteers, and the drug has not progressed to later-stage trials or regulatory approval.