NCT00520104Unknown1 期
A Randomized, Open Label, Single Center, Single-Dose Study to Assess the Effects of Certain Nasal Medications on the Pharmacokinetics, Safety and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg
Javelin Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.
详细描述
To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •Patients with Allergic Rhinitis
排除标准
- •Under age 18
研究组 & 干预措施
A
Experimental
intranasal ketamine
干预措施: intranasal ketamine (Drug)
B
Experimental
oxymetazoline plus intranasal ketamine
干预措施: intranasal ketamine (Drug)
C
Experimental
intranasal steroid plus intranasal ketamine
干预措施: intranasal ketamine (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: multiple
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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