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

NCT02126917 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-10

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Zogenix, Inc.

    lead INDUSTRY

Principal Investigators

  • James Kissling, MD · Zogenix, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2009-12-31
Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126917 on ClinicalTrials.gov