Clinical Trial Results:
A PHASE II, MONOCENTRE, OPEN, RANDOMIZED, 6-WAY
CROSS-OVER CLINICAL PHARMACOLOGY STUDY TO EVALUATE THE LUNG BIOAVAILABILITY OF BDP/B17MP AND FORMOTEROL AND THE TOTAL SYSTEMIC EXPOSURE ACROSS TWO DIFFERENT DOSE STRENGTHS OF CHF 1535 NEXThaler® DPI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE 100/6 µg and 200/6 µg) ADMINISTERED WITH AND WITHOUT ACTIVATED CHARCOAL IN ADULT ASTHMATIC PATIENTS
Summary
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EudraCT number |
2012-002370-30 |
Trial protocol |
GB |
Global completion date |
21 Jan 2013
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jan 2017
|
First version publication date |
06 Jan 2017
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Other versions |
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Summary report(s) |
EudraCT No. 2012-002370-30 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.