ACTRN12612000871842已完成1 期
Single-centre, single-dose, open-label, randomised, cross-over study of the effect of ibuprofen on the oxidative metabolism of paracetamol when administered as a fixed dose combination (Maxigesic) in healthy volunteers under fasting conditions.
AFT Pharmacetuicals Ltd0 个研究点目标入组 12 人开始时间: 2012年8月17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
- 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 50 Years（—）
- 性别
- All
入选标准
- •1) Provide written informed consent
- •2) Have Body Mass Index between 18.5 and 30.0 kg/m2
- •3) Healthy volunteers as determined by medical history, physical examination, ECG, vital signs and laboratory tests
排除标准
- •1) Women who are pregnant or nursing
- •2) Women who are unwilling to take adequate contraceptive precaustions or who are unwilling to undergo urine pregnancy testing
- •3) History of alcohol or drug abuse or dependency
- •4) Have a history of allergy or hypersensitivity to ibuprofen, aspirin, any other NSAID or paracetamol
- •5) Have haemopoetic, renal or hepatic disease, immunosupression. Have a history of gastric ulceration, indigestion, stomach pain, GI bleeding or bleeding disorders. Are currently suffering from dehydration from diarrhoea and/or vomiting. Have a history of severe asthma. Have a history of severe hypertension, ventricular tachycardia or other cardiac disease. Have insulin dependent diabetes mellitus.
研究者
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