The objective of this study was to obtain safety and tolerability data and first pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Number of patients with adverse events
Time frame: up to 30 days
Area under the curve (AUC)
Time frame: up to 24 hours after administration
Maximum concentration (Cmax)
Time frame: up to 24 hours after administration
Time to maximum concentration (tmax)
Time frame: up to 24 hours after administration
Apparent total plasma clearance (CLtot/f)
Time frame: up to 24 hours after administration
Apparent volume of distribution (Vz/f)
Time frame: up to 24 hours after administration
Elimination half-life (t1/2)
Time frame: up to 24 hours after administration
Amount excreted in urine (Ae)
Time frame: up to 24 hours after administration
Maximum flow rate (Qmax)
assessed by free uroflowmetry
Time frame: up to 8 hours after administration
Average flow rate (Qave)
assessed by free uroflowmetry
Time frame: up to 8 hours after administration
Voided volume (Vcomp)
assessed by free uroflowmetry
Time frame: up to 8 hours after administration
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Voiding time (T100)
assessed by free uroflowmetry
Time frame: up to 8 hours after administration
Time to maximum flow (TQmax)
assessed by free uroflowmetry
Time frame: up to 8 hours after administration
Residual urinary volume
assessed by means of transabdominal ultrasound evaluation
Time frame: up to 8 hours after administration
Assessment of micturition pattern
evaluated by Independent reviewer
Time frame: up to 8 hours after administration
Amount of inhibition constants (Ki) at α1A, adrenoreceptor subtype level
assessed by ex vivo radioreceptor assay
Time frame: up to 8 hours after administration