The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with BID treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Urinary excretion of dipyridamole
represented by the sum of percentage of amount excreted from time zer0 to 10 h (%Ae 0-10 h), %Ae 10-24h
Time frame: day 2, day 3
Cmax urine (Maximum measured concentration of the analyte)
Urine collected fraction from 0 -3 hours as surrogate for Cmax
Time frame: 0 to 3 hours after drug intake
Cmin urine (Minimum measured concentration of the analyte)
Urine collected fraction from 8 - 10 hours as surrogate for Cmin
Time frame: 8- 10 hours after drug intake
%PTF urine (Peak trough fluctuation)
Estimated from the difference of percentage amount excreted from 1 - 3 hours (%Ae (1-3hours) and %Ae (8-10 hours) divided by the average excretion rate over the total dosing interval
Time frame: Up to 10 hours after drug intake
Number of subjects with adverse events
Time frame: up to 23 days
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