This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] Antaitavir Hasophate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
100 mg suspension containing 200µCi of \[14C\] Antaitavir Hasophate
Shanghai xuhui central hospital
Shanghai, Shanghai Municipality, China
Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate
To investigate the pharmacokinetics of total radioactivity in plasma after oral \[14C\] Antaitavir Hasophate in healthy subjects, and the distribution ratio of total radioactivity in whole blood and plasma
Time frame: up to 15 days
Cumulative excretion of [14C] Antaitavir Hasophate -related material (radioactivity in plasma, urine and fecal samples)
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
Time frame: up to 15 days
Identification of the Proportion of different metabolites to determine biotransformation pathway of Antaitavir Hasophate
Proportion of different metabolites(Antaitavir Hasophate and main metabolites）
Time frame: up to 15 days
Quantitive analysis of the concentrations of Antaitavir Hasophate and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
The concentrations of Antaitavir Hasophate and main metabolites in plasma
Time frame: up to 15 days
Number of adverse events (AE) experienced by subjects
To examine the safety and tolerability of \[14C\] Antaitavir Hasophate given orally
Time frame: up to 15 days
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