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The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test-Reference Sequence | Experimental | SL spray, followed by SL film |
|
| Reference-Test Sequence | Experimental | SL film followed by SL spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SL spray | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone | within 21 days |
| Time to Cmax (Tmax) | Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone | within 21 days |
| Elimination rate constant | Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone | within 21 days |
| Elimination half-life (T½) | Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone | within 21 days |
| Area under the curve to the final sample with a concentration greater than the limit of quantification (LOQ [AUClast]) | Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone | within 21 days |
| Area under the curve extrapolated to infinity (AUCinf) | Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone | within 21 days |
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Inclusion Criteria:
Exclusion Criteria:
Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni DeCastro | INSYS Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials Early Phase Services, LLC | San Antonio | Texas | 78217 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| SL film | Drug |
|
|
| 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 |