CompletedNCT02336347Updated Apr 28, 2026

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

A Phase 1 interventional study of AVP-786 and AVP-923 in Healthy Volunteer, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 1, Interventional, and Other

From the registry’s dates

Registered 8 months after the study started (first participant enrolled May 2014, registered Jan 2015).

Phase: Phase 1
Study type: Interventional
Enrollment: 62
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Healthy Volunteer

Keywords

Pharmacokinetics
Healthy Volunteers
deuterated dextromethorphan
deuterated dextromethorphan with quinidine

In context

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

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

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 62 participants (actual)

Study arms

Experimental
Group 1 - Period 1
Twice daily dosing of AVP-786 orally for 8 days
Drug: AVP-786
Active comparator
Group 1 - Period 2
Twice daily dosing of AVP-923 orally for 8 days
Drug: AVP-923
Active comparator
Group 2 - Period 1
Twice daily dosing of AVP-923 orally for 8 days
Drug: AVP-923
Experimental
Group 2 - Period 2
Twice daily dosing of AVP-786 orally for 8 days
Drug: AVP-786

Interventions

DrugAVP-786
Also known as: deuterated (d6)-dextropmethorphan/quindine sulfate
DrugAVP-923
Also known as: dextromethorphan/quinidine

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Covance Dallas Clinical Research Unit
Dallas, Texas 75247, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02336347
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible party: Sponsor
First posted: Jan 13, 2015
Start date: May 1, 2014
Primary completion: Sep 1, 2014
Completion: Mar 1, 2015
Last update: Apr 28, 2026

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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