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

Avanir Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: AVP-923; Drug: AVP-786

Study type: Interventional

Funder types: Industry

Identifiers

NCT02336347

14-AVP-786-102

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

62 participants in 4 patient groups

Group 1 - Period 1

Experimental group

Description:

Twice daily dosing of AVP-786 orally for 8 days

Treatment:

Drug: AVP-786

Group 1 - Period 2

Active Comparator group

Description:

Twice daily dosing of AVP-923 orally for 8 days

Treatment:

Drug: AVP-923

Group 2 - Period 1

Active Comparator group

Description:

Twice daily dosing of AVP-923 orally for 8 days

Treatment:

Drug: AVP-923

Group 2 - Period 2

Experimental group

Description:

Twice daily dosing of AVP-786 orally for 8 days

Treatment:

Drug: AVP-786