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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02336347

Enrollment

Registered

2015-01-13

Start date

2014-05-01

Completion date

2015-03-01

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Pharmacokinetics, Healthy Volunteers, deuterated dextromethorphan, deuterated dextromethorphan with quinidine

Brief summary

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.

Interventions

DRUGAVP-786

DRUGAVP-923

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
PK of d6-DM in AVP-786 compared to DM in AVP-923	8 days

Secondary

Measure	Time frame
PK of metabolites	8 days
Safety and tolerability	8 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026