Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Area under the curve at steady state (AUCss)
Time frame: up to 72 hours after drug administration at day 7
Maximum concentration (Cmax,ss)
Time frame: up to 72 hours after drug administration at day 7
Time to maximum concentration (tmax)
Time frame: up to 72 hours after drug administration at day 7
Total apparent clearance (CLtot/f)
Time frame: up to 72 hours after drug administration at day 7
Apparent volume of distribution (Vz/f)
Time frame: up to 72 hours after drug administration at day 7
Mean residence time (MRTss)
Time frame: up to 72 hours after drug administration at day 7
Terminal half-life (t1/2)
Time frame: up to 72 hours after drug administration at day 7
Number of patients with adverse events
Time frame: up to 66 days
Number of patients with abnormal findings in physical examination
Time frame: up to 66 days
Number of patients with clinically relevant changes in electrocardiogram
Time frame: up to 66 days
Number of patients with clinically relevant changes in vital signs
Time frame: up to 66 days
Number of patients with abnormal changes in laboratory parameters
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Time frame: up to 66 days
Assessment of tolerability on a verbal rating scale
Time frame: between day 3 and 5 after last study drug administration