NCT01537692已完成1 期
A Randomized, Open-Label, 3-Period Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of BDP HFA Nasal Aerosol in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Pharmacokinetics
研究概览
简要总结
The purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent
- •Male or female subjects 18-45 years of age
- •General good health
排除标准
- •History of physical findings of nasal pathology (within 60 days prior to Screening Visit)
- •Participation in any investigational drug study 30 days preceding Screening Visit
- •History of respiratory infection/disorder with 28 days preceding Screening Visit
研究组 & 干预措施
BDP HFA Nasal Aerosol 80 mcg/d
Experimental
single dose, intranasal aerosol
干预措施: BDP HFA Nasal Aerosol (Drug)
BDP HFA Nasal Aerosol 320 mcg/d
Experimental
single dose, intranasal aerosol
干预措施: BDP HFA Nasal Aerosol (Drug)
BDP HFA Inhalation Aerosol 320 mcg/d
Active Comparator
single dose, orally inhaled aerosol
干预措施: BDP HFA Inhalation Aerosol (QVAR) (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 24 hours post dose
* Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP * Maximum plasma concentration (Cmax) for 17-BMP
次要结局
- Pharmacokinetics(24 hours post dose)
- Safety and tolerability of BDP HFA nasal aerosol(24 hours post dose)
研究者
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