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A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic ...

Update Il y a 4 ans
Reference: EUCTR2007-004507-36

A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects

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Extract

To evaluate the serum pharmacokinetics (PK) of inhaled TOBI® (AUC0-90’) of continuous daily dosing regimens with 2x300mg/d Tobramycin Nebulised Solution (=TNS) inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) subjects.

Inclusion criteria

  • patients with cystic fibrosis and chronical infection with Pseudomonas aeruginosa

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