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To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohorts A and C | Experimental | Single dose (D1) followed by twice daily dosing for 7 days |
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| Cohorts B and D | Experimental | Single dose (D1) followed by twice daily dosing for 7 days |
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| Cohorts E and F | Experimental | Single dose (D1) followed by twice daily dosing for 7 days |
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| Cohorts G and I | Experimental | Single dose (D1) followed by twice daily dosing for 7 days |
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| Cohorts H and J | Experimental | Single dose (D1) followed by twice daily dosing for 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVP-786 Dose 1 | Drug |
| ||
| AVP-786 Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of parent and metabolites | 8 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Assessments to include Physical Examination (PE), Labs, ECGs, and Adverse Events (AEs) | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX | Adelaide | South Australia | 5000 | Australia |
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| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
| Otsuka Clinical Trial Transparency | View source |
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| ID | Term |
|---|---|
| C507057 | dextromethorphan - quinidine combination |
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| AVP-786 Dose 1/Q Dose 1 | Drug |
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| AVP-786 Dose 1/Q Dose 2 | Drug |
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| AVP-786 Dose 2/Q Dose 2 | Drug |
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| AVP-923 | Drug |
|