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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
48
oral
oral
Covance CRU Ltd
Leeds, United Kingdom
Cardiovascular interactions assessed by blood pressure and pulse rate
Time frame: Pre-dose until 24 hours after dosing
Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events
Time frame: Arm 1: From time of combination dose until 4 days after combination dose / Arm 2: From time of combination dose until 8 days after combination dose
Potential PK interaction of the combination dosing assessed by serial plasma sampling
Time frame: Arm 1: From time of combination dose until 4 days after combination dose (10 time points) / Arm 2: From time of combination dose until 8 days after combination dose (14 time points)
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