NCT00662883已完成1 期
A Randomized, Open Label Study to Assess the Effects of a Nasal Corticosteroid on the Pharmacokinetics, Safety, and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg
Javelin Pharmaceuticals0 个研究点目标入组 18 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- Pharmacokinetic parameters
研究概览
简要总结
To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)
详细描述
Subjects will participate in a two-period, single-sequence study to assess the effects of administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults
- •nonsmoker
- •no drug use
排除标准
- •nasal abnormalities
- •airway abnormalities
研究组 & 干预措施
A
Experimental
- PMI-150 (intranasal ketamine HCl), day 1
- mometasone furoate, days 2-15
- PMI-150 (intranasal ketamine HCl), day 15
干预措施: PMI-150 (intranasal ketamine HCl); mometasone furoate (Drug)
结局指标
主要结局
Pharmacokinetic parameters
时间窗: 15 days
次要结局
未报告次要终点
研究者
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