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The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARC001 type I | Experimental | Treatment type I |
|
| SPARC001 type II | Experimental | Treatment type II |
|
| Reference001 type I | Active Comparator | Hydrocodone-Acetaminophen |
|
| Reference type II | Active Comparator | Hydrocodone-Acetaminophen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARC001 type I | Drug | Treatment type I |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | 48 hours | |
| Cmax | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | 25 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC Site 01 | Secaucus | New Jersey | 07094 | United States |
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| SPARC001 type II | Drug | Treatment type II |
|
| Reference001 type I | Drug | Hydrocodone-acetaminophen |
|
| Reference001 type II | Drug | Hydrocodone Acetaminophen |
|