A Phase 1 Study in Healthy Volunteers Investigating the Delivery of Tobramycin Using the TobrAir® 6.0 Device Compared With the Delivery of Marketed Tobramycin Nebuliser Solution (TOBI®) by PARI LC® PLUS and PARI TurboBoy® SX and With Delivery of Tobramycin by the TOBI® Podhaler™ Device, Using Pharmacokinetic and Pharmacoscintigraphic Methods.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Bioavailability of tobramycin
研究概览
简要总结
This study compares pharmacokinetic profiles of tobramycin delivered by TobrAir® 6.0 device with TOBI® nebulizer system and the TOBI® Podhaler™ device. In addition, lung deposition of tobramycin delivered by TobrAir® 6.0 device and by TOBI® nebulizer system will be determined.
详细描述
This is an open-label, randomized, single dose, cross-over study in healthy subjects. Each subject receives tobramycin with 3 different inhalation devices:
- 75 mg tobramycin delivered to the airways via TobrAir® 6.0.
- 300 mg tobramycin (TOBI®) delivered to the airways via the PARI LC® PLUS/PARI TurboBoy® SX.
- 112 mg tobramycin (4x28mg dry powder capsules) delivered to the airways via the TOBI® Podhaler™.
Each dose is separated by a minimum washout of at least 68 h.
Blood samples for PK analysis of tobramycin will be collected at regular time intervals until 24 h post-dose. For TobrAir 6.0 and TOBI/PARI only, all dosed subjects will undergo scintigraphic assessments.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or non-pregnant, non-lactating healthy females
- •Aged 18 to 65 years
- •Body mass index of 18.0 to 29.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- •Must provide written informed consent
- •Must agree to use an adequate method of contraception
排除标准
- •Participation in a clinical research study within the previous 3 months
- •Subjects who have previously been enrolled in this study
- •Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission and be using an appropriate method of contraception)
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- •History of chronic respiratory disorders (including asthma) as judged by the investigator
研究组 & 干预措施
TobrAir® 6.0
Tobramycin 75mg inhalation solution
干预措施: Tobramycin (Drug)
TOBI® / PARI LC® PLUS Nebulizer
Tobramycin 300mg nebulizer solution
干预措施: Tobramycin (Drug)
TOBI® Podhaler™
Tobramycin 112mg (4x28mg) inhalation powder
干预措施: Tobramycin (Drug)
结局指标
主要结局
Bioavailability of tobramycin
时间窗: 3 days
Bioavailability of tobramycin
次要结局
- Scintigraphic measurement of lung deposition of radiolabelled tobramycin(1 day)