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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Assess the rate and extent of absorption of HC-ER 50 mg capsule following co-ingestion of alcohol under fasted conditions.
研究概览
简要总结
To determine the influence of co-ingestion of alcohol on HC-ER.
详细描述
Determine the influence of co-ingestion of alcohol on the safety, pharmacokinetics, and relative bioavailability of HC-ER 50 mg under fasted conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, ages 21 to
- •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/m
- •Were medically healthy with no clinically significant abnormalities.
- •Voluntarily consented to participate in the study.
- •Were prepared to be compliant with the study procedures.
排除标准
- •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
- •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.
研究组 & 干预措施
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.
干预措施: HC-ER + 40% Alcohol (Drug)
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.
干预措施: HC-ER + 20% Alcohol (Drug)
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.
干预措施: HC-ER + 0% Alcohol (Drug)
结局指标
主要结局
Assess the rate and extent of absorption of HC-ER 50 mg capsule following co-ingestion of alcohol under fasted conditions.
时间窗: Day 1 through Day 18
次要结局
未报告次要终点