Study to investigate the effect of food intake on the bioavailability of a fixed dose combination of 80 mg telmisartan / 10 mg amlodipine following a high fat breakfast
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Fixed dose combination tablet
Area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity (AUC0-∞)
Time frame: up to 168 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 168 hours after drug administration
Area under the concentration-time curve of telmisartan and amlodipine in plasma over the time interval zero to the last quantifiable data point (AUC0-tz)
Time frame: up to 168 hours after drug administration
Time from dosing to the maximum concentration in plasma (tmax)
Time frame: up to 168 hours after drug administration
Terminal rate constant in plasma (λz)
Time frame: up to 168 hours after drug administration
Terminal half-life in plasma (t1/2)
Time frame: up to 168 hours after drug administration
Mean residence time in the body after po administration (MRTpo)
Time frame: up to 168 hours after drug administration
Apparent plasma clearance after p.o. administration (CL/F)
Time frame: up to 168 hours after drug administration
Apparent volume of distribution during the terminal phase λz after p.o. administration (Vz/F)
Time frame: up to 168 hours after drug administration
Number of subjects with adverse events
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Time frame: up to 65 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: day 8 after administration of study drug