A Single Dose PK Study of Oxycodone Hydrochloride Injection 2.5, 5, and 10mg in Chinese Patients With Cancer Pain or Post-operation Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) concentrations of oxycodone hydrochloride injection at various time points: predose, 0min, 2min, 5min, 10min, 15min, 30min, 45min, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24hr post dose.
研究概览
简要总结
This is a single center, open label, randomized, parallel group single dose intravenous (i.v.) administration study. The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg.
详细描述
After up to 7 days screening period, Eligible Patients will be randomized to 1 of 3 groups, and begin treatment with single dose of OxyNorm® 2.5,5, and 10mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with tumor pain / postoperative pain, or subjects with pain caused by other diseases;
- •Patients aged >30 to ≤ 60 years;
- •Body weight ≥ 45kg, and BMI range ≥19, <24;
- •Karnofsky score ≥ 70;
- •Expected survival is above 3 months;
- •The results of liver function and kidney tests must meet the following criteria:ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25;
- •The electrocardiogram examination results are normal;
- •Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test.
排除标准
- •Have hypersensitivity history to any opioids;
- •Have known hypersensitivity to any of compositions of the study drugs;
- •Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region；
- •Patients with respiratory depression, cor pulmonary, or chronic bronchial asthma;
- •Patient unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal;
- •Patients with hypercarbia;
- •Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency;
- •Patients with alcoholism or drug abuse history;
- •Positive ant-HIV or syphilis antibody test result;
- •Urine screening before study is positive for the opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids;
- •Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study.
- •Subjects who participated in a clinical research study within two months of study entry.
- •Patients who are currently taking opioids.
研究组 & 干预措施
Oxycodone (OxyNorm®) Injection
The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg
干预措施: Oxycodone (OxyNorm®) Injection (Drug)
结局指标
主要结局
Area under the curve (AUC) concentrations of oxycodone hydrochloride injection at various time points: predose, 0min, 2min, 5min, 10min, 15min, 30min, 45min, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24hr post dose.
时间窗: 2 days
Plasma concentrations of oxycodone and Noroxycodone and Oxymorphone will be analyzed.
次要结局
未报告次要终点