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To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - Period 1 | Experimental | Twice daily dosing orally for 7 days |
|
| Cohort A - Period 2 | Active Comparator | Twice daily dosing orally for 7 days |
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| Cohort A - Period 3 | Experimental | Twice daily dosing orally for 7 days |
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| Cohort B - Period 1 | Experimental | Twice daily dosing orally for 7 days |
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| Cohort B - Period 2 | Active Comparator | Twice daily dosing orally for 7 days |
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| Cohort B - Period 3 | Experimental | Twice daily dosing orally for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVP-786 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of AVP-786 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) for AVP-786 | 7 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-923 |
| Drug |
|