Healthy
Conditions
Keywords
Phase 1, Alcohol, Hydrocodone Bitartrate, Pharmacokinetics
Brief 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
Interventions
DRUGHC-ER + 40% Alcohol
HC-ER 50 mg + 240 mL solution of 40% alcohol/orange juice in fasted state
DRUGHC-ER + 20% Alcohol
HC-ER 50 mg + 240 mL solution of 20% alcohol/orange juice in fasted state
DRUGHC-ER + 0% Alcohol
HC-ER 50 mg + 240 mL solution of 0% alcohol/orange juice in fasted state
Sponsors
Zogenix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females, ages 21 to 45. * Female, must be of non-childbearing potential. * Non-smokers for at least 3 months or light smokers (less than 10 pack-years). * History of moderate consumption of between 7-21 units of alcohol per week. * Weighed at least 65 kg with a BMI ≥19 and ≤35 kg/m2. * Were medically healthy with no clinically significant abnormalities. * Voluntarily consented to participate in the study. * Were prepared to be compliant with the study procedures.
Exclusion criteria
* Women who were pregnant or breastfeeding. * History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. * History or presence of alcoholism or drug abuse. * Hypersensitivity or idiosyncratic reaction to morphine, hydrocodone (Vicodin) or other opioids; naltrexone, naloxone, or other opioid antagonist. * History of no alcohol intake (alcohol-naive) or less than moderate alcohol intake. * History of alcohol intake exceeding the equivalence of 21 units/week or exceeding the average of 3 drinks per day. * Surgery of the gastrointestinal tract which would interfere with absorption of the study drug. * Taken hepatic enzyme inducing drugs (e.g., Nizoral, Tagamet) within the previous 3 months. * Taken prescription medications within the previous 14 days or over the counter (OTC) medications within the previous 7 days prior to Day 1 Period 1. * Sitting blood pressure was less than 110/45 mmHg at screening. * On a special diet (except for vegetarians who agree to abide by study diet) during the 28 days prior to the first dose and throughout the study. * Significant blood donation or loss within 56 days prior to first dose of HC-ER. * Plasma donation within 7 days prior to first dose of HC-ER. * Hemoglobin value less than 12.0 g/dL. * Participated in another clinical trial within 28 days prior to first dose of HC-ER. * Positive urine test for drugs of abuse. * Positive test for, or had been treated for hepatitis B, hepatitis C or HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the rate and extent of absorption of HC-ER 50 mg capsule following co-ingestion of alcohol under fasted conditions. | Day 1 through Day 18 |
Outcome results
None listed