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To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and between AVP-786 and duloxetine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxetine + AVP-786 | Experimental | Paroxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20. |
|
| AVP-786 + paroxetine | Experimental | AVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20 |
|
| Duloxetine + AVP-786 | Experimental | Duloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13. |
|
| AVP-786 + duloxetine | Experimental | AVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVP-786 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects | 20 days | |
| Change in plasma concentration of AVP-786 (parent and metabolites) after dosing in combination with paroxetine. | 20 days | |
| Change in plasma concentration of duloxetine after combined dosing with AVP-786 | 13 days | |
| Change in plasma concentration of AVP-786 after combined dosing with duloxetine. | 13 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) for AVP-786 and paroxetine | 20 days | |
| Incidence of adverse events (AEs) for AVP-786 and duloxetine | 13 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Lickliter, MBBS PhD FRACP | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013876 | Thiophenes |
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| Paroxetine |
| Drug |
|
| Duloxetine | Drug |
|
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |