Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™
This trial is active, not recruiting.
|Start date||July 2014|
|End date||August 2014|
|Trial size||12 participants|
|Trial identifier||NCT02207426, 2013-005288-19, TobrAir - CT0040|
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.
|Endpoint classification||pharmacokinetics study|
|Intervention model||crossover assignment|
Tobramycin 75mg inhalation solution
Tobramycin 300mg nebulizer solution
Tobramycin 112mg (4x28mg) inhalation powder
Bioavailability of tobramycin
time frame: 3 days
Scintigraphic measurement of lung deposition of radiolabelled tobramycin
time frame: 1 day
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - 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
|Official title||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.|
|Description||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.|
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