To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Area under the concentration time curve from 48 to 58 hours (AUC48-58)
Time frame: 48 - 58 hours
Maximum concentration from 48 to 58 hours (Cmax48-58)
Time frame: 48 - 58 hours
Peak trough fluctuation (% PTF)
Time frame: up to 48 hours
Minimum concentration from 48 to 58 hours (Cmin48-58)
Time frame: 48 - 58 hours
Cmax48-58/AUC48-58 ratio
Time frame: 48 - 58 hours
Time to maximum concentration from 48 to 58 hours (Tmax48-58)
Time frame: up to 58 hours
Amount excreted in urine (Ae)
Time frame: up to 24 hours after drug administration
Number of participants with adverse events
Time frame: up to 8 days after last drug administration
Number of participants with clinically significant findings in vital functions
blood pressure, pulse rate
Time frame: up to 8 days after last drug administration
Number of participants with clinically significant findings in ECG
Time frame: up to 8 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
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Time frame: up to 8 days after last drug administration