NCT01319279已完成1 期
An Open-Label, Single-Dose, Parallel-Group Study to Assess the Pharmacokinetics of the Hydrocodone Bitartrate Extended-Release Tablet (15 mg) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment
Cephalon1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (AUC and Cmax) after a single dose
研究概览
简要总结
The purpose of this study is:
- To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.
- To assess the safety and tolerability of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects:
- •Written informed consent is obtained
- •Subjects with normal hepatic function:
- •The subject is in generally good health (age-appropriate) as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, coagulation, urinalysis, and serology.
- •Subjects with hepatic impairment:
- •The subject's health is otherwise clinically stable as determined by medical history, physical examination, ECG, serum chemistry, hematology, coagulation parameters (PT, activated partial thromboplastin time [aPTT], and international normalized ratio [INR]), urinalysis, and serology except for those signs and symptoms attributable to liver disease.
- •The subject has case record notes demonstrating physical signs consistent with 1 or more of the following characteristic clinical manifestations of liver cirrhosis: liver firmness to palpation, splenic enlargement, spider angiomas, palmar erythema, parotid hypertrophy, testicular atrophy, ascites (accumulation of fluid in the abdominal cavity), or gynecomastia.
- •The subject has a Child-Pugh Classification score of 7-9 points (moderate).
排除标准
- •All subjects:
- •The subject has any clinically significant, uncontrolled medical condition.
- •The subject is a poor metabolizer of CYP2D6 substrates based on genotyping performed at screening.
- •The subject has previously participated in a study with CEP-
- •The subject has a known sensitivity or idiosyncratic reaction to hydrocodone or hydromorphone, related compounds, or to any metabolites, or any compound listed as being present in a study formulation.
- •Subjects with normal hepatic function:
- •The subject has a positive test result for HBsAg or antibodies to hepatitis C.
- •The subject has a history of alcohol, narcotic, or any other substance abuse.
- •Subjects with hepatic impairment:
- •The subject has severe ascites.
- •The subject has an acute exacerbation of liver disease as indicated by worsening clinical signs of hepatic impairment.
研究组 & 干预措施
Normal Hepatic Function
Experimental
Intervention Drug: Hydrocodone bitartrate extended-release tablet
干预措施: Hydrocodone bitartrate extended-release tablet (Drug)
Moderate Hepatic Impairment
Experimental
Intervention Drug: Hydrocodone bitartrate extended-release tablet
干预措施: Hydrocodone bitartrate extended-release tablet (Drug)
结局指标
主要结局
Pharmacokinetics (AUC and Cmax) after a single dose
时间窗: 7 days
次要结局
- Safety (occurrence of adverse events, labs, ECG, physical exam, vital signs, oxygen saturation)(throughout the 37 day study period (includes screening, drug administration and pharmacokinetics sampling period, and follow-up))
研究者
研究点 (1)
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