The aim of this study is to evaluate the effect of urine acid-base disequilibrium on the pharmacokinetics of captopril in healthy male volunteers.
* Pharmacokinetic analysis of captopril before and after urine acid-base imbalance * Safety analysis
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
12
Seoul National University Hospital
Seoul, Seoul, South Korea
AUClast of captopril
Area under the concentration-time curve from 0 to last measurable concentration (AUClast)
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
Cmax of captopril
Maximum concentration of captopril (Cmax)
Time frame: Observed value among pre-dose (0 hour) and up to 12 hours in each period
AUCinf of captopril
Area under the concentration-time curve from 0 to infinite (AUCinf)
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
Tmax of captopril
Time to Cmax (Tmax)
Time frame: Observed time point among pre-dose (0 hour) and up to 12 hours in each period
t1/2 of captopril
half-life (t1/2)
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
CL/F of captopril
Apparent clearance (CL/F)
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
Vd/F of captopril
Apparent volume of distribution (Vd/F)
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
fe of captopril
Fraction of urinary excretion (fe)
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
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urine pH
urine pH
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
Safety parameters
Number and frequency of participants observed adverse events in each period
Time frame: Through study completion, an average of 3 months