ACTRN12616000317493已完成1 期
Single-centre, single-dose, open-label, randomised, three-period cross-over study to evaluate the pharmacokinetic parameters of acetaminophen and ibuprofen fixed dose oral combinations, acetaminophen with tramadol hydrochloride, fixed dose oral combination and ibuprofen oral formulation in healthy volunteers, under fed conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Healthy volunteers, males and females aged 18 to 50 years of age. Females must be sterile or using adequate contraception. Participants must not have taken any prescription medications for at least 14 days or over-the-counter medications for at least 7 days before the start of each study phase, with the exception of oral contraceptives and the study medication.
- •All subjects must be deemed healthy on the basis of a medical history, physical exam (including vital signs and ECG recording), urinalysis, and blood biochemical and haematological examinations.
排除标准
- •Pregnancy, nursing, drug abuse, smoking>10 cigarettes per day, excess alcohol intake, prescription drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal laboratory tests
研究者
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