Healthy Subjects Clinical Trial
Official title:
A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin
The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.
Treatment arm 1 (effect of mirabegron on tamsulosin): Subjects are randomized into one of
two sequences.
Subjects receive 2 singles doses of tamsulosin, once in the absence of mirabegron and once
in the presence of mirabegron.
24-hour Cardiovascular (CV) profiles are taken at both baseline days and after the single
dose of tamsulosin /combination dose in each sequence. Regular blood samples are also taken
to check for a potential Pharmacokinetic (PK) interaction.
Treatment arm 2 (effect of tamsulosin on mirabegron): Subjects are randomized into one of
two sequences.
Subjects receive 2 singles doses of mirabegron, once in the absence of tamsulosin and once
in the presence of tamsulosin.
24-hour CV profiles are taken at both baseline days and after the single dose of
mirabegron/combination dose in each sequence. Regular blood samples are also taken to check
for a potential PK interaction.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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