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The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator |
| |
| Treatment B | Experimental |
| |
| Treatment C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test formulation administered with water | Drug | single dose of 20 mg of test formulation with 240 mL of water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed oxycodone concentration in plasma (Cmax) | hours after dosing | |
| Area under the oxycodone concentration versus time curve (AUC) | hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-peak concentration (Tmax) | hours after dosing | |
| half-life of drug | hours after dosing | |
| Vital signs and adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25724154 | Derived | Malhotra BK, Matschke K, Wang Q, Bramson C, Salageanu J. Effects of ethanol on the pharmacokinetics of extended-release oxycodone with sequestered naltrexone (ALO-02). Clin Drug Investig. 2015 Apr;35(4):267-74. doi: 10.1007/s40261-015-0278-6. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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 |
|
|
| hours after dosing |
| ID | Term |
|---|---|
| D014867 | Water |
| C000608978 | oxycodone naltrexone combination |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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