drugset / Trial / NCT02207426

Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™

NCT02207426

Phase 1 Completed 12 enrolled Pharmaero ApS
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2014-07
Primary completion
2014-08
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Tobramycin Small molecule 75 mg Inhaled
Subject Tobramycin Small molecule 112 mg Inhaled
Subject Tobramycin Small molecule 300 mg Inhaled

Indications

No indication recorded.