A Phase 1 Study Comparing AVP-786 With AVP-923

NCT ID: NCT02336347

Last Updated: 2015-07-13

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

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-03-31

Brief Summary

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To compare pharmacokinetics (PK) of AVP-786 (deuterated \[d6\] dextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) to AVP-923 (dextromethorphan hydrobromide \[DM\]/Q) at steady state.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1 - Period 1

Twice daily dosing of AVP-786 orally for 8 days

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Group 1 - Period 2

Twice daily dosing of AVP-923 orally for 8 days

Group Type ACTIVE_COMPARATOR

AVP-923

Intervention Type DRUG

Group 2 - Period 1

Twice daily dosing of AVP-923 orally for 8 days

Group Type ACTIVE_COMPARATOR

AVP-923

Intervention Type DRUG

Group 2 - Period 2

Twice daily dosing of AVP-786 orally for 8 days

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Interventions

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AVP-786

Intervention Type DRUG

AVP-923

Intervention Type DRUG

Other Intervention Names

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deuterated (d6)-dextropmethorphan/quindine sulfate dextromethorphan/quinidine

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males or females
* 18 - 60 years of age
* BMI 18 - 32 kg/m2

Exclusion Criteria

* History or presence of significant disease
* History of substance abuse and/or alcohol abuse with the past 2 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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Avanir Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadine Knowles

Role: STUDY_DIRECTOR

Avanir Pharmaceuticals

Locations

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Covance Dallas Clinical Research Unit

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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14-AVP-786-102

Identifier Type: -

Identifier Source: org_study_id

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