Clinical Trial Results:
A comparative, randomised, two period, multi-center, cross-over 14 weeks
bioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) in
cystic fibrosis patients with bronchopulmonary chronic Pseudomonas
aeruginosa infection
Summary
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|
EudraCT number |
2010-023235-41 |
Trial protocol |
PL |
Global completion date |
12 Jul 2012
|
Paediatric regulatory details
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|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
03 Jan 2020
|
First version publication date |
03 Jan 2020
|
Other versions |
|
Summary report(s) |
CSR EudraCT Number 2010-023235-41 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.