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OpenTrials
Completed

NCT Number: NCT02336347

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Dallas Clinical Research Unit

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVP-786

Drug

Other names: deuterated (d6)-dextropmethorphan/quindine sulfate

AVP-923

Drug

Other names: dextromethorphan/quinidine

Primary outcomes

  1. PK of d6-DM in AVP-786 compared to DM in AVP-923

    Time frame: 8 days

Secondary outcomes

  1. PK of metabolites

    Time frame: 8 days

  2. Safety and tolerability

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, 2-way Crossover Study Comparing AVP-786 With AVP-923

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jan 13, 2015
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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