To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Area under the concentration-time curve of simvastatin and simvastatin acid in plasma at different time points (AUC)
Time frame: Pre-dose, up to day 32 after start of treatment
Maximum concentration of simvastatin and simvastatin acid in plasma (Cmax)
Time frame: Pre-dose, up to day 32 after start of treatment
Time to Cmax after a single extravascular dose (tmax)
Time frame: Pre-dose, up to day 32 after start of treatment
Elimination half-life in plasma (t1/2)
Time frame: Pre-dose, up to day 32 after start of treatment
Total clearance from plasma (CLtot/f)
Time frame: Pre-dose, up to day 32 after start of treatment
Mean time of residence in the body (MRTtot)
Time frame: Pre-dose, up to day 32 after start of treatment
Apparent volume of distribution during the terminal phase (Vz/f)
Time frame: Pre-dose, up to day 32 after start of treatment
Area under the plasma concentration-time curve of telmisartan at steady state (AUCss)
Time frame: Pre-dose, up to day 32 after start of treatment
Maximum concentration of telmisartan in plasma at steady state (Cmax,ss)
Time frame: Pre-dose, up to day 32 after start of treatment
Number of patients with clinically relevant findings in laboratory values
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Pre-dose, up to day 32 after start of treatment
Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)
Time frame: Pre-dose, up to day 32 after start of treatment
Number of patients with adverse events
Time frame: Up to day 32 after start of treatment
Number of patients with clinically relevant findings in ECG
Time frame: Pre-dose, up to day 32 after start of treatment