ACTRN12613000398707已完成1 期
An open label, single dose, phase I pilot study in healthy volunteers to determine the pharmacokinetic, safety and tolerability profiles of oxycodone delivered from a transdermal oxycodone patch to promote pain relief.
Phosphagenics Limited0 个研究点目标入组 12 人开始时间: 2013年4月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •Healthy male subjects, aged 18 to 55 years inclusive, body mass index greater than or equal to 19 and less than or equal to 27 kg/m2, weight >50 kg, free from clinically significant illness or disease, as defined.
排除标准
- •* Evidence of clinically significant impairment/disorders.
- •* History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
- •* Have a rested systolic blood pressure of < 90 mmHg or > 160 mmHg and/or diastolic blood pressure of < 50 mmHg or > 95 mmHg.
- •* History of obstructive airway disease or any condition that may increase the risk for respiratory depression.
- •* A resting pulse rate at rest of < 45 Beats Per Minute (BPM) or > 100 BPM.
- •* History of neurologic conditions or convulsive disorders, severe head injury or increased intracranial pressure.
- •* A calculated creatinine clearance of < 85 mL/minute
- •* Have undergone surgery or received anaesthetic within 30 days of Day 1.
- •* Use of central nervous system depressants within 30 days of Day 1.
- •* Use of macrolide antibiotics, azole antifungal agents or protease inhibitors within 30 days of Day 1.
- •* Use of any prescription medication, over the counter product, herbal product, diet aid, or hormone supplement, within 14 days of Day 1 and for duration of study.
- •* Known intolerance, allergy or hypersensitivity reactions to naltrexone, naloxone, oxycodone, opioid analgesics, or any commercially available adhesives.
- •* Any history of a dermatological condition or recurrent generalised skin disorder within the last 5 years.
- •* Any tattoos, bruises, scars or skin lesions on the area where the patch is to be applied.
- •* Consumption of grapefruit, grapefruit juice or any products containing CYP3A4 inhibitors and inducers within 14 days of Day 1 and through to discharge.
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