Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277 capsule
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Cmax (maximum observed concentration of the Telmisartan in plasma)
Time frame: up to 72 hours after drug administration
AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr
Time frame: up to 72 hours after drug administration
Individual time courses of the Telmisartan plasma concentrations
Time frame: up to 72 hours after drug administration
tmax (time to reach Cmax)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of the Telmisartan in plasma)
Time frame: up to 72 hours after drug administration
AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity)
Time frame: up to 72 hours after drug administration
MRT0-∞ (total mean residence time of Telmisartan molecules in the body)
Time frame: up to 72 hours after drug administration
Number of subjects with adverse events
Time frame: up to 72 hours after drug administration
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate
Time frame: up to 72 hours after drug administration
Number of subjects with clinically significant findings in ECG
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Time frame: up to 72 hours after drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 72 hours after drug administration