NCT02336347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

January 8, 2015

Last Update Submit

April 23, 2026

Conditions

Healthy Volunteer

Keywords

PharmacokineticsHealthy Volunteersdeuterated dextromethorphandeuterated dextromethorphan with quinidine

Outcome Measures

Primary Outcomes (1)

  • PK of d6-DM in AVP-786 compared to DM in AVP-923

    8 days

Secondary Outcomes (2)

  • PK of metabolites

    8 days

  • Safety and tolerability

    8 days

Study Arms (4)

Group 1 - Period 1

EXPERIMENTAL

Twice daily dosing of AVP-786 orally for 8 days

Drug: AVP-786

Group 1 - Period 2

ACTIVE COMPARATOR

Twice daily dosing of AVP-923 orally for 8 days

Drug: AVP-923

Group 2 - Period 1

ACTIVE COMPARATOR

Twice daily dosing of AVP-923 orally for 8 days

Drug: AVP-923

Group 2 - Period 2

EXPERIMENTAL

Twice daily dosing of AVP-786 orally for 8 days

Drug: AVP-786

Interventions

AVP-786DRUG
Also known as: deuterated (d6)-dextropmethorphan/quindine sulfate
Group 1 - Period 1Group 2 - Period 2
AVP-923DRUG
Also known as: dextromethorphan/quinidine
Group 1 - Period 2Group 2 - Period 1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Dallas Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Related Links

MeSH Terms

Interventions

dextromethorphan - quinidine combination

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

March 1, 2015

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

US(1)