This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single oral dose of \[14C\]-20 mg/100 μCi Anaprazole Sodium enteric-coated capsule in healthy adult male subjects. Whole blood, plasma samples will be collected at hour 0 pre-dose and 1,2,3,4,5,6,8,12,24,48,72,96,120,144,168 hours post-dose (tentative, adjusted according to plasma drug concentration); urine samples will be collected at hour 24 pre-dose and 0-4,4-8,8-12,12-24,24-48,48-72,72-96,96-120,120-144,144-168,168-192,192-216,216-240 hours post-dose (tentative, adjusted according to sample recovery rate) ; fecal samples will be collected at hour 24 pre-dose and 0-24,24-48,48-72,72-96,96-120,120-144,144-168,168-192,192-216,216-240 hours post-dose (tentative, adjusted according to sample recovery rate) following the start of administration to measure total radioactivity and plasma drug concentrations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
\[14C\]-Anaprazole Sodium enteric-coated capsule
Cmax of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma
Cmax is the peak plasma concentration
Time frame: Hour 0 pre-dose and 1,2,3,4,5,6,8,12,24,48,72,96,120,144,168 hours post-dose (tentative, adjusted according to plasma drug concentration)
Tmax of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma
Tmax is the time to maximum plasma concentration
Time frame: Hour 0 pre-dose and 1,2,3,4,5,6,8,12,24,48,72,96,120,144,168 hours post-dose (tentative, adjusted according to plasma drug concentration)
AUC of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma
AUC is area under the plasma concentration-time curve
Time frame: Hour 0 pre-dose and 1,2,3,4,5,6,8,12,24,48,72,96,120,144,168 hours post-dose (tentative, adjusted according to plasma drug concentration)
Cumulative excretion and cumulative excretion rate in urine
Sum of the percent of the total radioactivity recovered in urine relative to the administered radioactivity dose
Time frame: Hour 24 pre-dose and 0-4,4-8,8-12,12-24,24-48,48-72,72-96,96-120,120-144,144-168,168-192,192-216,216-240 hours post-dose (tentative, adjusted according to sample recovery rate)
Cumulative excretion and cumulative excretion rate in feces
Sum of the percent of the total radioactivity recovered in feces relative to the administered radioactivity dose
Time frame: Hour 24 pre-dose and 0-24,24-48,48-72,72-96,96-120,120-144,144-168,168-192,192-216,216-240 hours post-dose (tentative, adjusted according to sample recovery rate)
Radioactivity spectrum indentification of metabolites in plasma
plasma concentration of metabolites
Time frame: Hour 0 pre-dose and 1,2,3,4,5,6,8,12,24,48,72,96,120,144,168 hours post-dose (tentative, adjusted according to plasma drug concentration)
Radioactivity spectrum indentification of metabolites in urine
Concentration of metabolites in urine
Time frame: Hour 24 pre-dose and 0-4,4-8,8-12,12-24,24-48,48-72,72-96,96-120,120-144,144-168,168-192,192-216,216-240 hours post-dose (tentative, adjusted according to sample recovery rate)
Concentration of metabolites in feces
Sum of the percent of the total radioactivity recovered in feces relative to the administered radioactivity dose
Time frame: Hour 24 pre-dose and 0-24,24-48,48-72,72-96,96-120,120-144,144-168,168-192,192-216,216-240 hours post-dose (tentative, adjusted according to sample recovery rate)
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