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This study aims to determine whether the hydrocodone and acetaminophen exposures following oral dosing of Vycavert are comparable to those following oral dosing of Norco.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: single dose Vycavert (Test) | Experimental |
| |
| B: single dose Norco (Reference) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vycavert | Drug | single dose Vycavert containing 10 mg hydrocodone bitartrate/325 mg acetaminophen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of hydrocodone. | 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose | |
| Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of acetaminophen | 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose | |
| Cmax (maximum plasma concentration) of of hydrocodone | 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose | |
| Cmax (maximum plasma concentration) of acetaminophen | 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of hydromorphone and norhydrocodone | 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose | |
| Cmax of hydromorphone and norhydrocodone | 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 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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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
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| Norco | Drug | single dose Norco containing 10 mg hydrocodone bitartrate/325 mg acetaminophen |
|
| T1/2 (half life) as data permit of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen | 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose |
| Tmax (Time at maximum concentration) of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen | 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose |
| Adverse events, vital signs, pulse oximetry and laboratory parameters. | 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose |