Clinical Trial Results:
A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the
Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release
Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases
Summary
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EudraCT number |
2014-001642-16 |
Trial protocol |
IT PL |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Jun 2022
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First version publication date |
16 Jun 2022
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Other versions |
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Summary report(s) |
TAK-390MR_108_2014-001642-16_EudraCT PDF |
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.