Clinical Trial Results:
A single-dose, open-label, randomized, 2-way crossover, clinical pharmacology study of four inhalations of CHF 1535 100/6 NEXT DPI® (fixed combination of beclomethasone dipropionate 100μg plus formoterol fumarate 6 μg) versus the same dose of CHF 1535 100/6 pMDI both administered with charcoal block.
Summary
|
|
EudraCT number |
2010-024384-40 |
Trial protocol |
GB |
Global completion date |
09 Jun 2011
|
Paediatric regulatory details
|
|
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 |
06 Jan 2017
|
First version publication date |
06 Jan 2017
|
Other versions |
|
Summary report(s) |
EudraCT No. 2010-024384-40 ICH E3 Synopsis |
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.