A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Avanir Pharmaceuticals
• Treatments: Dextromethorphan; Quinidine

Criteria

Inclusion Criteria:

• Healthy adult males

• 18 - 45 years of age

• BMI 18 - 30 kg/m2

Exclusion Criteria:

• History or presence of significant disease

• History of substance abuse and/or alcohol abuse with the past 3 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