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A Phase 1, Single-center, Open-label, Sequential Drug Interaction Study Between AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [DM]/Quinidine Sulfate [Q]) and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
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.
Details
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 56 |
| Start date | 2014-01 |
| Completion | 2014-04 |
Conditions
- Drug-drug Interaction
Interventions
- AVP-786
- Paroxetine
- Duloxetine
Primary outcomes
- 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
Countries
Australia