A comparative, randomised, two period, multi-centre, cross-over 14 weeks bioequivalence study of Tobramycin PARI (T100) versus TOBI (Novartis) in cystic fibrosis patients with bronchopulmonary chronic Pseudomonas aeruginosa (PA) infection

Trial Profile

A comparative, randomised, two period, multi-centre, cross-over 14 weeks bioequivalence study of Tobramycin PARI (T100) versus TOBI (Novartis) in cystic fibrosis patients with bronchopulmonary chronic Pseudomonas aeruginosa (PA) infection

Completed
Phase of Trial: Phase I

Latest Information Update: 07 Jul 2015

At a glance

  • Drugs Tobramycin (Primary)
  • Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
  • Focus Pharmacokinetics
  • Acronyms T100
  • Sponsors PARI Pharma GmbH
  • Most Recent Events

    • 09 Sep 2013 Results presented at the 23rd Annual Congress of the European Respiratory Society.
    • 31 Aug 2011 Status changed from recruiting to completed as reported by ISRCTN: Current Controlled Trials.
    • 14 Apr 2011 New trial record
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