Healthy Clinical Trial
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.
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.
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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