\[14 C\] Mass balance clinical trial of TY-9591 in healthy Chinese subjects
This is a single-center, non-randomized, one-arm, open trial in healthy adult subjects. The study population is male healthy subjects. The trial consisted of a screening period, a trial period and a follow-up period. A total of 6-10 healthy Chinese adult male subjects were planned to be enrolled and divided into groups according to specific conditions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
C14 TY-9591
Suzhou first people's hospital
Suzhou, Jiangsu, China
The total radioactivity in whole blood and plasma after a single oral administration of 14C TY-9591
The total radioactivity in excreta after oral administration of 14C TY-9591
Time frame: After oral administration of 14C TY-9591, the radiometabolite profiles of plasma, urine and stool were obtained to identify the major metabolites
The concentrations of TY-9591 by the verified LC-MS/MS method to obtain the pharmacokinetic parameters of TY-9591 and its metabolites D1 and D2 or ot
To observe the safety of 14C TY-9591 in healthy subjects after a single dose
Time frame: 8m
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