Study to investigate the effect of CYP3A4 inhibition by ketoconazole on the single oral dose pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Cmax (maximum measured concentration of Tamsulosin HCl in plasma)
Time frame: up to 48 hours after dosing
AUC0-∞ (Area under the concentration-time curve of Tamsulosin HCl in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 48 hours after dosing
tmax (time from dosing to the maximum concentration of Tamsulosin HCl in plasma)
Time frame: up to 48 hours after dosing
AUC0-tz (area under the concentration-time curve of Tamsulosin HCl in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 48 hours after dosing
λz (terminal rate constant of Tamsulosin HCl in plasma)
Time frame: up to 48 hours after dosing
t1/2 (terminal half-life of Tamsulosin HCl in plasma)
Time frame: up to 48 hours after dosing
MRTpo (mean residence time Tamsulosin HCl in the body after oral administration)
Time frame: up to 48 hours after dosing
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 48 hours after dosing
Vz/F (apparent volume of distribution of Tamsulosin HCl during the terminal phase λz following an extravascular dose)
Time frame: up to 48 hours after dosing
Number of subjects with adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 21 days after last Tamsulosin administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 21 days after last Tamsulosin administration
Ratio of the Cmax value of the Test treatment to the Cmax value of the Reference treatment after single dose (RCmax,T/R)
Time frame: up to 48 hours after dosing
Ratio of the Test treatment versus the Reference treatment from zero to infinity, expressed as ratio of AUC values after single dose (RAUC0-∞,T/R)
Time frame: up to 48 hours after dosing