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The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
Bioavailability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions. |
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| B | Experimental | 1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast). |
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| C | Experimental | 1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALO-02 (Oxycodone Naltrexone) | Drug | single dose of ALO-02 capsule under fasting condition |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) to time infinity (inf) of oxycodone | predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose | |
| Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone | predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose | |
| Maximum Plasma Concentration (Cmax) of oxycodone | predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit. | predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose | |
| AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit | predose, 1,2,4,8,12,24,48,120 hours post-dose |
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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 |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ALO-02 (Oxycodone Naltrexone) |
| Drug |
single dose of ALO-02 capsule under fed condition |
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| ALO-02 (Oxycodone Naltrexone) | Drug | ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions. |
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| Adverse events, vital signs, pulse oximetry, and safety laboratory parameters. | over 120 hours |
| ID | Term |
|---|---|
| C000608978 | oxycodone naltrexone combination |
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