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The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group AB | Experimental | Subjects in this group will receive study drug in the following sequence:
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| Treatment Group BA | Experimental | Subjects in this group will receive study drug in the following sequence:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 90 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 45-mg tablets (Treatment A) or one 90-mg tablet (Treatment B). | Drug | Each subject will receive 1 treatment during each administration period. Subjects will receive each of the 2 treatments once. There will be a minimum 14-day washout period between the 2 administrations of study drug. Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma drug concentration (Cmax) | To assess the bioequivalence between 45-mg tablets and one 90-mg tablet of the hydrocodone bitartrate extended-release tablet. | Up to 72 hrs after each dose of study drug |
| Area under the plasma drug concentration by time curve AUC0-∞ | To assess bioequivalence between two 45-mg tablets and one 90-mg tablet of the hydrocodone bitartrate extended-release tablet. | Up to 72 hrs after each dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed plasma drug concentration (tmax) | To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet. | Up to 72 hrs after each dose of study drug |
| AUC from time 0 to 72 hours after study drug administration (AUC0-72) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 10470 | Austin | Texas | United States |
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To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet. |
| Up to 72 hrs after each dose of study drug |
| AUC from time 0 to the time of the last measurable drug concentration (AUC0-t) | To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet. | Up to 72 hrs after each dose of study drug |
| Percentage extrapolation, 100x(AUC0-∞-AUC0-t)/AUC0-∞) | To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet. | Up to 72 hrs after each dose of study drug |
| Apparent plasma terminal elimination rate constant (λz) and associated elimination half life (t½) | To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet. | Up to 72 hrs after each dose of study drug |
| Recording of Adverse Events | To characterize the safety of the hydrocodone bitartrate extended-release tablet in healthy naltrexone-blocked subjects. | Adverse events will be collected for the duration of the study which is approximately 7 weeks |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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