The study aimed to compare age and gender differences for increasing doses of mirabegron when given to healthy young and elderly males and healthy young and elderly females.
Each subject will receive a single dose of mirabegron OCAS-M or placebo on Day 2, followed by multiple dosing (qd) for 10 days (Day 5-14). Young subjects will be divided into 4 groups and elderly subjects into 2 groups. Dosage will be different among groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
96
oral
oral
Kendle Nederland
Utrecht, Netherlands
Pharma Bio Research
Zuidlaren, Netherlands
Pharmacokinetics of mirabegron assessed by plasma concentration
Time frame: Pre-dose until 72 hours after dosing
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events
Time frame: Baseline until 72 hours after dosing
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