ACTRN12614001152617已完成1 期
An Open-label, Randomized, Single-dose, 4-way Crossover Study to Assess the Relative Bioavailability of Axelopran and Oxycodone Administered as a Fixed-Dose Combination and as Individual Components to Healthy Subjects with a Naltrexone Block Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
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
- Randomised controlled 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
- All
入选标准
- •healthy weight, BMI, medical history and on physical exam
- •- females must not be pregnant and males and females must practice approved contraception during the study
- •- screening lab assessments must have normal healthy results
- •- able to comply with study requirements and give informed consent
排除标准
- •- history or evidence of severe allergic, or other disease as determined by the investigator to be of clinical significance
- •- history of chronic obstructive pulmonary disease, asthma or reactive airway disease
- •- history of, or current hypersensitivity to drugs
- •- any condition which may affect drug absorption
- •- recent participation in a trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to screening.
- •- Unwilling to abstain from caffeine products or alcohol or strenuous exercise beginning 24 hours prior to admission on Day -1 until the final PK sample is collected for each period.
- •- Consumption of grapefruit or grapefruit juice within 14 days prior to admission on Day -1.
- •- Consumption of other fruit juices within 24 hours prior to admission to the unit on Day -1 of any period.
- •- history of alcoholism or drug abuse
- •- history of tobacco use within previous 6 months
- •- Use of prescription or over-the-counter medications including herbals within 7 days (or14 days if the drug is a potent inducer or inhibitor of cytochrome P450 isoenzyme 3A4 or permeability glycoprotein 1, or five half-lives (whichever is longer) prior to Day -1 or requires continuous use during study participation, with the exception of routine vitamins or minerals, paracetamol (up to 1000 mg/day) if required, ibuprofen (up to 400 mg/day) if required, or ondansetron IV (up to 8 mg /day) if required.
- •- Blood donors within 8 weeks prior to screening
- •-abnormal ECG or family history of congenital long QT syndrome or family history of sudden death
研究者
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