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Safety parameters assessed included medical history, physical examination, vital signs, 12-lead ECGs, clinical laboratory testing and adverse event assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HC-ER 20 mg capsule (fasted) | Experimental | Single oral dose of a HC-ER 20 mg capsule (fasted) |
|
| HC-ER 20 mg capsule (fed) | Experimental | Single oral dose of HC-ER 20mg capsule (fed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HC-ER 20 mg capsule (fasted) | Drug | Single oral dose HC-ER 20 mg capsule after overnight fast (fasted) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in both fed and fast states | Day 1-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A. Johnston Stewart, MB, MRCGP | Zogenix, Inc. | Principal Investigator |
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| ID | Term |
|---|---|
| D006853 | Hydrocodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| HC-ER 20 mg capsule (fed) | Drug | Single oral dose HC-ER 20 mg capsule after high fat meal (fed) |
|
|
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |