Clinical Trial Results:
Single-Dose, Two Treatment, Four-Way Crossover Replicate Design to Assess the Bioequivalence of two Fentanyl Transdermal Delivery Systems MYLAN (25ug/h) and Durogesic Dtrans (25ug/h) in Healthy Volunteers under Naltrexone Block.
Summary
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EudraCT number |
2005-002935-28 |
Trial protocol |
GB |
Global completion date |
02 Feb 2007
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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 |
17 Jun 2022
|
First version publication date |
17 Jun 2022
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Other versions |
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Summary report(s) |
FENT-05104 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.