ACTRN12621001252808撤回1 期
A single dose, blinded, balanced, randomised, three-treatment, three-period, six-sequence, three-way crossover study to compare the efficacy and pharmacokinetics of 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid with 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid and placebo oral liquid in healthy male and female subjects under fasting conditions.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 30
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Healthy males and non-pregnant female volunteers.
- •Aged between 18 and 50
- •Non-smoker
- •BMI between 18 and 32
- •Absence of any cough or cold within 2 weeks prior to dosing.
- •Normal spirometry measurements (FEV1).
- •Cough response reached in the Citric Acid Provocation test at screening and pre-dose.
- •Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests.
- •Able to provide written informed consent.
排除标准
- •Concomitant drug therapy of any kind
- •Any clinically significant medical conditions
- •Sensitive to the study drug
- •History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •No cough response reached at any concentration of the citric acid test during screening.
- •History of bronchial asthma, chronic obstructive pulmonary disease (COPD).
- •History of recent head injuries, constipation, hypothyroidism or sleep apnoea
- •Females who are pregnant and/or breastfeeding
- •Smoker (anyone who has smoked in the last 6 months)
- •History of alcohol or drug abuse or dependency
- •Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study
- •Participants for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
研究者
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