A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Drug-drug Interaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Paroxetine + AVP-786

Paroxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20.

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Paroxetine

Intervention Type DRUG

AVP-786 + paroxetine

AVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Paroxetine

Intervention Type DRUG

Duloxetine + AVP-786

Duloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13.

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Duloxetine

Intervention Type DRUG

AVP-786 + duloxetine

AVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13.

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Duloxetine

Intervention Type DRUG

Interventions

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AVP-786

Intervention Type DRUG

Paroxetine

Intervention Type DRUG

Duloxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males and females
* 18 - 50 years of age
* BMI 18 - 30 kg/m2

Exclusion Criteria

* History or presence of significant disease
* History of substance abuse and/or alcohol abuse with the past 3 years
* Use of tobacco-containing or nicotine-containing products within 6 months
* Use of any prescription or the over-the-counter medications within 14 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes