A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER)
NCT ID: NCT02126917
Last Updated: 2022-11-10
Study Results
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Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2009-11-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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HC-ER + 40% Alcohol
Open-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 40% Alcohol.
HC-ER + 40% Alcohol
HC-ER 50 mg + 240 mL solution of 40% alcohol/orange juice in fasted state
HC-ER + 20% Alcohol
Open-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 20% Alcohol.
HC-ER + 20% Alcohol
HC-ER 50 mg + 240 mL solution of 20% alcohol/orange juice in fasted state
HC-ER + 0% Alcohol
Open-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 0% Alcohol.
HC-ER + 0% Alcohol
HC-ER 50 mg + 240 mL solution of 0% alcohol/orange juice in fasted state
Interventions
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HC-ER + 40% Alcohol
HC-ER 50 mg + 240 mL solution of 40% alcohol/orange juice in fasted state
HC-ER + 20% Alcohol
HC-ER 50 mg + 240 mL solution of 20% alcohol/orange juice in fasted state
HC-ER + 0% Alcohol
HC-ER 50 mg + 240 mL solution of 0% alcohol/orange juice in fasted state
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
45 Years
ALL
Yes
Sponsors
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Zogenix, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James Kissling, MD
Role: PRINCIPAL_INVESTIGATOR
Zogenix, Inc.
Other Identifiers
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ZX002-0901
Identifier Type: -
Identifier Source: org_study_id
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