NCT02126917

A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER)

Single-center, Open-Label, 3-Period Crossover, Phase 1 Study to Evaluate the Pharmacokinetics of Hydrocodone Bitartrate Extended-Release (HC-ER) Capsules 50 mg When Co-Administered With Alcohol in Healthy Subjects Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To determine the influence of co-ingestion of alcohol on HC-ER.

Detailed description

Determine the influence of co-ingestion of alcohol on the safety, pharmacokinetics, and relative bioavailability of HC-ER 50 mg under fasted conditions

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HC-ER + 40% Alcohol	HC-ER 50 mg + 240 mL solution of 40% alcohol/orange juice in fasted state
DRUG	HC-ER + 20% Alcohol	HC-ER 50 mg + 240 mL solution of 20% alcohol/orange juice in fasted state
DRUG	HC-ER + 0% Alcohol	HC-ER 50 mg + 240 mL solution of 0% alcohol/orange juice in fasted state

Timeline

• Start date: 2009-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2014-04-30
• Last updated: 2022-11-10