To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use
Purpose:
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
64
Telmisartan80mg/Amlodipin5mg FDC
Telmisartan 80 mg tablet
Amlodipin 5mg tablet
1235.28.001 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto, Japan
AUC0-tz
Area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Cmax
maximum measured concentration of Telmisartan in plasma
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
AUC0-∞
area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Tmax
time from dosing to the maximum concentration of Telmisartan in plasma
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
λz
terminal rate constant of Telmisartan in plasma
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
t1/2
terminal half-life of Telmisartan in plasma
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
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MRTpo
mean residence time of Telmisartan in the body after oral administration
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration