EUCTR2008-001575-30-GB进行中（未招募）不适用
A randomised, open-label, single-centre, pharmacokinetic study of a single dose of lorazepam administered by the intranasal and buccal route in healthy adult volunteers - Lorazepam Pharmacokinetics after Intranasal and Buccal Administration
niversity of Nottingham0 个研究点目标入组 12 人开始时间: 2008年7月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Males, aged 18 to 35 years, and BMI 19 - 28
- •2.No chronic oral or nasal symptoms
- •3.Provision of and capacity to give written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Participation in healthy volunteer study within last 3 months
- •2.Tobacco use within the last 2 years
- •3.Alcohol or substance abuse within the last 5 years
- •4.Recent history of prescription or OTC medication use
- •5.Major surgery within the last 6 months
- •6.Subjects with renal or hepatic impairment
- •7.Subjects with cardiac disease
- •8.Subjects with any GI inflammatory disease
- •9.Diabetics
- •10.Allergies to any of the components of the product (listed in SmPC)
- •11.Subjects with any medical condition that, in the opinion of the investigators, might impact on the outcome of the trial or the safety of the subject
研究者
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